HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs)

New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Reyataz atazanavir 20/06/03 2003 NCE 1 1,722 Bristol-Myers Squibb (USA) Infections viral
Velcade bortezomib 13/05/03 2003 NCE 1 1 1 1 1 1,718 Millenium Pharmaceuticals (USA) Cancer
Namenda memantine hydrochloride 16/10/03 2003 NCE 1 1,450 Forest Laboratories (USA) CNS/Pain/Behaviour
Cialis tadalafil 21/11/03 2003 NCE 1,390 Eli Lilly (USA) Urology/Nephrology
Iressa gefitinib 05/05/03 2003 NCE 1 1 1 1 680 AstraZeneca (UK) Cancer
Emend aprepitant 27/03/03 2003 NCE 1 1 416 Merck & Co. (USA) Cancer
Raptiva Efalizumab 27/10/03 2003 Biologic 1 400 Genentech (USA) Immunology
Xolair Omalizumab 20/06/03 2003 Biologic 1 350 Genentech (USA) Respiratory
Amevive Alefacept 30/01/03 2003 Biologic 1 267 Biogen (USA) Immunology
Aloxi palonosetron hydrochloride 25/07/03 2003 NCE 250 MGI Pharma (USA) Cancer
Factive gemifloxacin mesylate 04/04/03 2003 NCE 250 LG Group (Korea) Infections bacterial
Plenaxis abarelix 25/11/03 2003 NCE 1 1 125 Praecis Pharmaceuticals (USA) Cancer
Levitra vardenafil hydrochloride 19/08/03 2003 NCE 50 Bayer (Germany) Urology/Nephrology
Somavert pegvisomant 25/03/03 2003 NCE 1 1 1 1 n.a. Pfizer (USA) Diabetes/Metabolic/Endocrinology
Crestor rosuvastatin 12/08/03 2003 NCE n.a. AstraZeneca (UK) Cardiovascular/Vascular
Boniva ibandronate sodium 16/05/03 2003 NCE n.a. Roche (Switzerland) Women's Health
Zavesca miglustat 31/07/03 2003 NCE 1 1 1 n.a. Actelion (Switzerland) Genetic
Ertaczo sertaconazole nitrate 10/12/03 2003 NCE n.a. Mylan (USA) Infections fungal
Aldurazyme Laronidase 30/04/03 2003 Biologic 1 1 1 n.a. Genzyme (USA) Genetic
Fabrazyme Agalsidase beta 24/04/13 2003 Biologic 1 1 1 n.a. Genzyme (USA) Genetic
Emtriva emtricitabine 02/07/03 2003 NCE 1 n.a. Gilead Sciences (USA) Infections viral
Elestat epinastine hydrochloride 16/10/03 2003 NCE 1 n.a. Allergan (USA) Ophthalmology
Cubicin Daptomycin 12/09/03 2003 NCE 1 1 n.a. Cubist Pharmaceuticals (USA) Infections bacterial
Fuzeon enfuvirtide 13/03/03 2003 NCE 1 1 1 n.a. Roche (Switzerland) Infections viral
Uroxatral alfuzosin hydrochloride 12/06/03 2003 NCE n.a. Sanofi (France) Urology/Nephrology
Alimta pemetrexed disodium 04/02/04 2004 NCE 1 1 1 3,150 Eli Lilly (USA) Cancer
Lyrica pregabalin 30/12/04 2004 NCE 1 3,000 Pfizer (USA) CNS/Pain/Behaviour

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 1
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Tarceva erlotinib hydrochloride 18/11/04 2004 NCE 1 1 1,431 Genentech (USA) Cancer
Erbitux cetuximab 12/02/04 2004 Biologic 1 1 1 1 735 ImClone Systems (USA) Cancer
Tysabri natalizumab 23/11/04 2004 Biologic 1 1 725 Biogen (USA) Immunology
Clolar clofarabine 28/12/04 2004 NCE 1 1 1 1 475 Genzyme (USA) Cancer
Apidra insulin glusilin recombinant 16/04/04 2004 NCE 200 Aventis (Germany) Diabetes/Metabolic/Endocrinology
Apokyn apomorphine hydrochloride 20/04/04 2004 NCE 1 1 1 37 Mylan (USA) CNS/Pain/Behaviour
Ketek telithromycin 01/04/04 2004 NCE n.a. Aventis (Germany) Infections bacterial
Sensipar cinacalcet hydrochloride 08/03/04 2004 NCE 1 1 1 n.a. Amgen (USA) Diabetes/Metabolic/Endocrinology
Cymbalta duloxetine hydrochloride 03/08/04 2004 NCE n.a. Eli Lilly (USA) CNS/Pain/Behaviour
Campral acamprosate calcium 29/07/04 2004 NCE 1 1 n.a. Forest Laboratories (USA) CNS/Pain/Behaviour
Nutrestore glutamine 10/06/04 2004 NCE 1 n.a. Cato Research (USA) Gastroenterology
Sanctura trospium chloride 28/05/04 2004 NCE n.a. Indevus (USA) Urology/Nephrology
Vidaza azacitidine 19/05/04 2004 NCE 1 1 1 1 n.a. Pharmion (UK) Cancer
Spiriva tiotropium bromide 30/01/04 2004 NCE n.a. Boehringer Ingelheim (Germany) Respiratory
monohydrate
Xifaxan (Normrifaximin 25/05/04 2004 NCE n.a. Salix Pharmaceuticals (USA) Infections bacterial
Macugen pegaptanib sodium 17/12/04 2004 NCE 1 1 n.a. Eyetech Pharma (USA) Ophthalmology
Fosrenol Lanthanum carbonate 26/10/04 2004 NCE n.a. Shire (Ireland) Urology/Nephrology
Omacor hydrate
Omega-3-acid Ethyl Esters 10/11/04 2004 NCE n.a. Reliant Pharmaceuticals (USA) Cardiovascular/Vascular
Vesicare solifenacin 19/11/04 2004 NCE n.a. Astellas (Japan) Urology/Nephrology
Lunesta eszopiclone 15/12/04 2004 NCE n.a. Sepracor (USA) CNS/Pain/Behaviour
Enablex darifenacin hydrobromide 22/12/04 2004 NCE n.a. Novartis (Switzerland) Urology/Nephrology
Prialt ziconotide acetate 28/12/04 2004 NCE 1 1 n.a. Elan (Ireland) CNS/Pain/Behaviour
Tindamax tinidazole 17/05/04 2004 NCE 1 n.a. Presutti Laboratories (USA) Infections bacterial
Kepivance palifermin 15/12/04 2004 Biologic 1 1 n.a. Amgen (USA) Cancer
Ventavis iloprost 29/12/04 2004 NCE 1 1 n.a. CoTherix (USA) Cardiovascular/Vascular
Avastin bevacizumab 26/02/04 2004 Biologic 1 1 1 n.a. Genentech (USA) Cancer
Revlimid lenalidomide 27/12/05 2005 NCE 1 1 1 1 5,616 Celgene (USA) Hematology

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 2
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Byetta exenatide 28/04/05 2005 NCE 1 2,500 Amylin (USA) Diabetes/Metabolic/Endocrinology

Orencia abatacept 23/12/05 2005 Biologic 1 1 1 1,813 Bristol-Myers Squibb (USA) Immunology
Baraclude entecavir 29/03/05 2005 NCE 1 1,743 Bristol-Myers Squibb (USA) Infections viral
Levemir insulin detemir 16/06/05 2005 NCE 1,708 Novo Nordisk (Denmark) Diabetes/Metabolic/Endocrinology
Exjade deferasirox 02/11/05 2005 NCE 1 1 1 1 1,045 Novartis (Switzerland) Hematology
Nexavar sorafenib tosylate 20/12/05 2005 NCE 1 1 1 1 445 Bayer (Germany) Cancer
Tygacil tigecycline 15/06/05 2005 NCE 1 308 Wyeth (USA) Infections bacterial
Iplex mecasermin rinfabate 12/12/05 2005 NCE 1 1 250 Insmed (USA) Genetic
Symlin pramlintide acetate 16/03/05 2005 NCE 1 105 Amylin (USA) Diabetes/Metabolic/Endocrinology
Increlex mecasermin 30/08/05 2005 NCE 1 1 100 Tercica (USA) Genetic
Vaprisol conivaptan hydrochloride 29/12/05 2005 NCE 1 n.a. Astellas (Japan) Diabetes/Metabolic/Endocrinology
Arranon nelarabine 28/10/05 2005 NCE 1 1 1 1 1 n.a. GlaxoSmithKline (UK) Cancer
Nevanac nepafenac 19/08/05 2005 NCE 1 n.a. Alcon (Switzerland) Ophthalmology
Rozerem ramelteon 22/07/05 2005 NCE 1 n.a. Takeda (Japan) CNS/Pain/Behaviour
Aptivus tipranavir 22/06/05 2005 NCE 1 1 n.a. Boehringer Ingelheim (Germany) Infections viral
Naglazyme galsulfase 31/05/05 2005 Biologic 1 1 1 1 n.a. Biomarin (USA) Genetic
Mycamine micafungin sodium 16/03/05 2005 NCE 1 n.a. Astellas (Japan) Infections fungal
Januvia sitagliptin phosphate 16/10/06 2006 NCE 1 5,200 Merck & Co. (USA) Diabetes/Metabolic/Endocrinology
Lucentis ranibizumab 30/06/06 2006 Biologic 1 2,869 Genentech (USA) Ophthalmology
Sprycel dasatinib 28/06/06 2006 NCE 1 1 1 1 1,700 Bristol-Myers Squibb (USA) Cancer
Sutent sunitinib malate 26/01/06 2006 NCE 1 1 1 1,416 Pfizer (USA) Cancer
Invega paliperidone 19/12/06 2006 NCE 1,036 Johnson & Johnson (USA) CNS/Pain/Behaviour
Myozyme alglucosidase alpha 28/04/06 2006 Biologic 1 1 1 1 1,000 Genzyme (USA) Genetic
Chantix varenicline tartrate 10/05/06 2006 NCE 1 1 800 Pfizer (USA) CNS/Pain/Behaviour
Elaprase idursulfase 24/07/06 2006 Biologic 1 1 1 1 771 Shire (Ireland) Genetic
Azilect rasagiline 16/05/06 2006 NCE 635 Teva (Israel) CNS/Pain/Behaviour
Ranexa ranolazine 27/01/06 2006 NCE 1 556 CV Therapeutics (USA) Cardiovascular/Vascular

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 3
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Vectibix panitumumab 27/09/06 2006 Biologic 1 1 1 500 Amgen (USA) Cancer

Prezista darunavir 23/06/06 2006 NCE 1 1 1 400 Johnson & Johnson (USA) Infections viral
Zolinza vorinostat 06/10/06 2006 NCE 1 1 1 1 346 Merck & Co. (USA) Cancer
Eraxis anidulafungin 17/02/06 2006 NCE 264 Pfizer (USA) Infections fungal
Dacogen decitabine 02/05/06 2006 NCE 1 1 250 MGI Pharma (USA) Cancer
Noxafil posaconazole 15/09/06 2006 NCE 1 162 Schering Plough (USA) Infections fungal
Amitiza lubiprostone 31/01/06 2006 NCE 1 100 Sucampo (USA) Gastroenterology
Pylera biskalcitrate, metronidazole, 28/09/06 2006 NCE n.a. Aptalis/Axcan (USA) Infections bacterial
Omnaris tetracycline
ciclesonide hydrochloride 20/10/06 2006 NCE n.a. Altana (Germany) Respiratory
Tyzeka telbivudine 25/10/06 2006 NCE n.a. Novartis (Switzerland) Infections viral
Veregen kunecatechins 31/10/06 2006 NCE 1 n.a. Medigene (Germany) Infections viral
Isentress raltegravir potassium 12/10/07 2007 NCE 1 1 1 2,000 Merck & Co. (USA) Infections viral
Tasigna nilotinib 29/10/07 2007 NCE 1 1 1,680 Novartis (Switzerland) Cancer
Vyvanse lisdexamfetamine dimesylate 23/02/07 2007 NCE 1,412 Shire (Ireland) CNS/Pain/Behaviour
Tekturna aliskiren fumarate 05/03/07 2007 NCE 1 1,037 Novartis (Switzerland) Cardiovascular/Vascular
Mircera methoxy polyethylene glycol- 14/11/07 2007 Biologic 950 Roche (Switzerland) Hematology
Bystolic epoetin
nebivololbeta
hydrochloride 17/12/07 2007 NCE 800 Forest Laboratories (USA) Cardiovascular/Vascular
Letairis ambrisentan 15/06/07 2007 NCE 1 1 1 670 Gilead Sciences (USA) Cardiovascular/Vascular
Tykerb lapatinib 13/03/07 2007 NCE 1 1 665 GlaxoSmithKline (UK) Cancer
Neupro rotigotine 09/05/07 2007 NCE 440 UCB (Belgium) CNS/Pain/Behaviour
Torisel temsirolimus 30/05/07 2007 NCE 1 1 416 Wyeth (USA) Cancer
Doribax doripenem 12/10/07 2007 NCE 384 Johnson & Johnson (USA) Infections bacterial
Somatuline delanreotide 30/08/07 2007 NCE 1 350 Ipsen Biopharm (France) Diabetes/Metabolic/Endocrinology
Altabax retapamulin 12/04/07 2007 NCE 240 GlaxoSmithKline (UK) Infections bacterial
Selzentry maraviroc 06/08/07 2007 NCE 1 1 1 211 Pfizer (USA) Infections viral
Ixempra ixabepilone 16/10/07 2007 NCE 1 164 Bristol-Myers Squibb (USA) Cancer
Kuvan sapropterin dihydrochloride 13/12/07 2007 NCE 1 1 1 70 Biomarin (USA) Genetic

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 4
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Soliris eculizumab 16/03/07 2007 Biologic 1 1 1 n.a. Alexion (USA) Genetic

Vimpat lacosamide 28/10/08 2008 NCE 1,600 UCB (Belgium) CNS/Pain/Behaviour
Treanda bendamustine hydrochloride 20/03/08 2008 NCE 1 1 1,000 Cephalon (USA) Cancer
Cimzia certolizumab pegol 22/04/08 2008 Biologic 900 UCB (Belgium) Gastroenterology
Relistor methylnaltrexone bromide 24/04/08 2008 NCE 865 Salix Pharmaceuticals (USA) Gastroenterology
Pristiq desvenlafaxine succinate 29/02/08 2008 NCE 661 Wyeth (USA) CNS/Pain/Behaviour
Intelence etravirine 18/01/08 2008 NCE 1 1 605 Johnson & Johnson (USA) Infections viral
Nplate romiplostim 22/08/08 2008 Biologic 1 1 1 530 Amgen (USA) Immunology
Toviaz fesoterodine fumarate 31/10/08 2008 NCE 527 Pfizer (USA) Urology/Nephrology
Nucynta tapentadol hydrochloride 20/11/08 2008 NCE 390 Johnson & Johnson (USA) CNS/Pain/Behaviour
Entereg alvimopan 20/05/08 2008 NCE 250 Adolor (USA) Gastroenterology
Xenazine tetrabenazine 15/08/08 2008 NCE 1 1 242 Biovail (Canada) Genetic
Mozobil plerixafor 15/12/08 2008 NCE 1 1 200 Genzyme (USA) Cancer
Cleviprex clevidipine butyrate 01/08/08 2008 NCE 200 Medicines Company (USA) Cardiovascular/Vascular
Arcalyst rilonacept 27/02/08 2008 Biologic 1 1 200 Regeneron Pharmaceuticals (USA) Genetic
Promacta eltrombopag olamine 20/11/08 2008 NCE 1 1 1 150 GlaxoSmithKline (UK) Immunology
Firmagon degarelix 24/12/08 2008 NCE n.a. Ferring (Switzerland) Cancer
Lusedra fospropofol disodium 12/12/08 2008 NCE n.a. Eisai (Japan) CNS/Pain/Behaviour
Durezol difluprednate 23/06/08 2008 NCE 1 n.a. Sirion Therapeutics (USA) Ophthalmology
Banzel rufinamide 14/11/08 2008 NCE 1 1 n.a. Eisai (Japan) CNS/Pain/Behaviour
Rapaflo silodosin 08/10/08 2008 NCE n.a. Actavis Watson (Ireland) Cancer
Simponi golimumab 24/04/09 2009 Biologic 4,500 Johnson & Johnson (USA) Immunology
Afinitor everolimus 30/03/09 2009 NCE 1 2,000 Novartis (Switzerland) Cancer
Multaq dronedarone Hcl 01/07/09 2009 NCE 1 1,400 Sanofi (France) Cardiovascular/Vascular
Saphris Asenapine 13/08/09 2009 NCE 1,000 Schering Plough (USA) CNS/Pain/Behaviour
Stelara ustekinumab 25/09/09 2009 Biologic 1 1,000 Johnson & Johnson (USA) Immunology
Onglyza saxagliptin hydrochloride 31/07/09 2009 NCE 1,000 Bristol-Myers Squibb (USA) Diabetes/Metabolic/Endocrinology

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 5
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Effient prasugrel 10/07/09 2009 NCE 1 695 Eli Lilly (USA) Cardiovascular/Vascular
Livalo pitavastatin 03/08/09 2009 NCE 580 Kowa (Japan) Cardiovascular/Vascular
Votrient pazopanib 19/10/09 2009 NCE 500 GlaxoSmithKline (UK) Cancer
Arzerra ofatumumab 26/10/09 2009 Biologic 1 1 1 1 350 GlaxoSmithKline (UK) Cancer
Ilaris canakinumab 17/06/09 2009 Biologic 1 1 1 350 Novartis (Switzerland) Genetic
Uloric febuxostat 13/02/09 2009 NCE 200 Takeda (Japan) Diabetes/Metabolic/Endocrinology
Savella milnacipran hydrochloride 14/01/09 2009 NCE 200 Forest Laboratories (USA) CNS/Pain/Behaviour
Istodax romidepsin 05/11/09 2009 NCE 1 106 Gloucester Pharmaceuticals (UK) Cancer
Vibativ telavancin 11/09/09 2009 NCE 100 Theravance (USA) Infections bacterial
Sabril vigabatrin 21/08/09 2009 NCE 1 83 Lundbeck (Denmark) CNS/Pain/Behaviour
Besivance besifloxacin HCL 28/05/09 2009 NCE n.a. Bausch & Lomb (USA) Ophthalmology
Kalbitor ecallantide 27/11/09 2009 NCE 1 1 1 n.a. Dyax (USA) Genetic
Ulesfia Benzyl Alcohol 09/04/09 2009 NCE n.a. Sciele (USA) Infections parasitic
Bepreve bepotastine besilate 08/09/09 2009 NCE n.a. ISTA Pharmaceuticals (USA) Ophthalmology
Samsca ophtalmic
tolvaptan solution 19/05/09 2009 NCE n.a. Otsuka Pharmaceutical (Japan) Diabetes/Metabolic/Endocrinology
Coartem Arthemether, Lumefantrine 07/04/09 2009 NCE 1 1 1 1 n.a. Novartis (Switzerland) Infections bacterial
Dysport abobotulinumtoxinA 29/04/09 2009 Biologic 1 1 n.a. Ipsen Biopharm (France) CNS/Pain/Behaviour
Qutenza Capsaicin 16/11/09 2009 NCE 1 n.a. Neurogesx (USA) CNS/Pain/Behaviour
Folotyn pralatrexate injection 24/09/09 2009 NCE 1 1 1 n.a. Allos (USA) Cancer
Fanapt iloperidone 06/05/09 2009 NCE n.a. Vanda Pharmaceuticals (USA) CNS/Pain/Behaviour
Gilenya fingolimod 21/09/10 2010 NCE 1 1 1 3,000 Novartis (Switzerland) Immunology
Victoza liraglutide 25/01/10 2010 NCE 2,500 Novo Nordisk (Denmark) Diabetes/Metabolic/Endocrinology
Actemra tocilizumab 08/01/10 2010 Biologic 1 2,200 Roche (Switzerland) Immunology
Pradaxa dabigatran etexilate 19/10/10 2010 NCE 1 2,000 Boehringer Ingelheim (Germany) Hematology
Lumizyme alglucosidase alfa 24/05/10 2010 Biologic 1 1 1,800 Genzyme (USA) Genetic
Prolia denosumab 01/06/10 2010 Biologic 1 821 Amgen (USA) Women's Health
Jevtana Kit cabazitaxel 17/06/10 2010 NCE 1 1 700 Sanofi (France) Cancer

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 6
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Halaven eribulin mesylate 15/11/10 2010 NCE 1 1 1 695 Eisai (Japan) Cancer
Natazia estradiol valerate and 06/05/10 2010 NCE 600 Bayer (Germany) Women's Health
Krystexxa estradiol valerate/dienogest
pegloticase 14/09/10 2010 Biologic 1 1 550 Savient Pharmaceuticals (USA) Diabetes/Metabolic/Endocrinology
Latuda lurasidone hydrochloride 28/10/10 2010 NCE 410 Dainippon Sumitomo (Japan) CNS/Pain/Behaviour
Xiaflex collagenase clostridium 02/02/10 2010 Biologic 1 1 1 400 Auxilium Pharmaceuticals (USA) Dermatology
Ampyra histolyticum
dalfampridine 22/01/10 2010 NCE 1 1 300 Acorda Therapeutics (USA) Immunology
Egrifta tesamorelin acetate 10/11/10 2010 NCE 1 250 Theratechnologies (Canada) Diabetes/Metabolic/Endocrinology
Vpriv velaglucerase alfa 26/02/10 2010 Biologic 1 1 220 Shire (Ireland) Genetic
Teflaro ceftaroline fosamil 29/10/10 2010 NCE 1 200 Forest Laboratories (USA) Infections bacterial
Ella ulipristal acetate tablet 13/08/10 2010 NCE 25 HRA Pharma (France) Women's Health
Lastacaft alcaftadine ophtalmic solution 28/07/10 2010 NCE n.a. Johnson & Johnson (USA) Ophthalmology
Asclera polidocanol 30/03/10 2010 NCE n.a. Merz Pharma (Germany) Cardiovascular/Vascular
Carbaglu Carglumic acid 18/03/10 2010 NCE 1 1 1 n.a. Recordati Group (Italy) Genetic
Xeomin incobotulinum toxin 30/07/10 2010 Biologic n.a. Merz Pharma (Germany) CNS/Pain/Behaviour
Incivek Telaprevir 23/05/11 2011 NCE 1 1 2,900 Vertex Pharmaceuticals (USA) Infections viral
Eylea aflibercept 18/11/11 2011 Biologic 1 1,800 Regeneron Pharmaceuticals (USA) Ophthalmology
Victrelis boceprevir 13/05/11 2011 NCE 1 1 1 1,700 Merck & Co. (USA) Infections viral
Yervoy ipilimumab 25/03/11 2011 Biologic 1 1 1 1 1,700 Bristol-Myers Squibb (USA) Cancer
Xarelto rivaroxaban 01/07/11 2011 NCE 1 1,650 Johnson & Johnson (USA) Hematology
Brilinta ticagrelor 20/07/11 2011 NCE 1,600 AstraZeneca (UK) Cardiovascular/Vascular
Zytiga abiraterone acetate 28/04/11 2011 NCE 1 1 1,363 Johnson & Johnson (USA) Cancer
Tradjenta Linagliptin 02/05/11 2011 NCE 1,335 Boehringer Ingelheim (Germany) Diabetes/Metabolic/Endocrinology
Benlysta belimumab 09/03/11 2011 Biologic 1 1 1 1,280 Human Genome Science (USA) Immunology
Xalkori crizotinib 26/08/11 2011 NCE 1 1 1 1 1 954 Pfizer (USA) Cancer
Zelboraf vemurafenib 17/08/11 2011 NCE 1 1 1 1 758 Roche (Switzerland) Cancer
Adcetris brentuximab vedotin 19/08/11 2011 Biologic 1 1 1 1 1 610 Seattle Genetics (USA) Cancer
Potiga ezogabine 10/06/11 2011 NCE 1 600 Valeant (Canada) CNS/Pain/Behaviour

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 7
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Edarbi azilsartan medoxomil 25/02/11 2011 NCE 500 Takeda (Japan) Cardiovascular/Vascular
Arcapta Neohaindacaterol 01/07/11 2011 NCE 464 Novartis (Switzerland) Respiratory
Edurant rilpivirine hydrochloride 20/05/11 2011 NCE 458 Johnson & Johnson (USA) Infections viral
Jakafi ruxolitinib 16/11/11 2011 NCE 1 1 1 1 415 Incyte Corporation (USA) Cancer
Nulojix belatacept 15/06/11 2011 Biologic 1 1 1 400 Bristol-Myers Squibb (USA) Immunology
Ferriprox deferiprone 14/10/11 2011 NCE 1 1 1 365 Apotex (Canada) Genetic
Viibryd vilazodone hydrochloride 21/01/11 2011 NCE 350 Clinical Data (USA) CNS/Pain/Behaviour
Erwinaze asparaginase erwinia 18/11/11 2011 Biologic 1 1 1 270 Eusa Pharma (UK) Cancer
Firazyr chrysanthemi
icatibant acetate 25/08/11 2011 NCE 1 1 1 1 200 Shire (Ireland) Genetic
Onfi clobazam 21/10/11 2011 NCE 1 175 Lundbeck (Denmark) CNS/Pain/Behaviour
Dificid fidaxomicin 27/05/11 2011 NCE 1 1 161 Optimer Pharmaceuticals (USA) Infections bacterial
Daliresp roflumilast 28/02/11 2011 NCE 1 152 Forest Laboratories (USA) Respiratory
Caprelsa vandetanib 06/04/11 2011 NCE 1 1 1 128 AstraZeneca (UK) Cancer
Horizant Gabapentin enacabril 06/04/11 2011 NCE 121 GlaxoSmithKline (UK) CNS/Pain/Behaviour
Natroba spinosad 18/01/11 2011 NCE 114 Parapro (USA) Infections parasitic
Eliquis apixaban 28/12/12 2012 NCE 1 3,800 Bristol-Myers Squibb (USA) Cardiovascular/Vascular
Xeljanz tofacitinib citrate 06/11/12 2012 NCE 1 2,600 Pfizer (USA) Immunology
Xtandi enzalutamide 31/08/12 2012 NCE 1 1 2,317 Medivation (USA) Cancer
Belviq lorcaserin hydrochloride 27/06/12 2012 NCE 1 2,250 Arena Pharmaceuticals (USA) Diabetes/Metabolic/Endocrinology
Perjeta pertuzumab 08/06/12 2012 Biologic 1 2,250 Roche (Switzerland) Cancer
Kalydeco ivacaftor 31/01/12 2012 NCE 1 1 1 1 2,100 Vertex Pharmaceuticals (USA) Genetic
Stribild cobicistat, elvitegravir, 27/08/12 2012 NCE 1 1,767 Gilead Sciences (USA) Infections viral
Kyprolis emtricitabine,tonofovir
carfilzomib 20/07/12 2012 NCE 1 1 1 1,580 Onyx Pharmaceuticals (USA) Cancer
Erivedge disoproxil
vismodegibfumarate 30/01/12 2012 NCE 1 1 1,111 Roche (Switzerland) Cancer
Fycompa perampanel 22/10/12 2012 NCE 1 1,000 Eisai (Japan) CNS/Pain/Behaviour
Jetrea ocriplasmin 17/10/12 2012 Biologic 1 1 875 Thrombogenics (Belgium) Ophthalmology
Iclusig ponatinib hydrochloride 14/12/12 2012 NCE 1 1 1 1 810 Ariad Pharmaceuticals (USA) Cancer

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 8
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Linzess linaclotide 30/08/12 2012 NCE 1 715 Forest Laboratories (USA) Gastroenterology
Cometriq cabozantinib s-malate 29/11/12 2012 NCE 1 1 1 1 639 Exelixis (USA) Cancer
Aubagio teriflunomide 12/09/12 2012 NCE 1 600 Sanofi (France) Immunology
Myrbetriq mirabegron 28/06/12 2012 NCE 1 576 Astellas (Japan) Urology/Nephrology
Omontys peginesatide acetate 27/03/12 2012 NCE 500 Affymax (USA) Hematology
Stivarga regorafenib 27/09/12 2012 NCE 1 1 500 Bayer (Germany) Cancer
Tudorza Pressaclidinium bromide 23/07/12 2012 NCE 496 Forest Laboratories (USA) Respiratory
Inlyta axitinib 27/01/12 2012 NCE 1 475 Pfizer (USA) Cancer
Elelyso taliglucerase alpha 01/05/12 2012 NCE 1 1 400 Pfizer (USA) Genetic
Gattex Kit teduglutide recombinant 21/12/12 2012 NCE 1 1 375 NPS Pharmaceuticals (USA) Gastroenterology
Signifor pasireotide daspartate 14/12/12 2012 NCE 1 1 369 Novartis (Switzerland) Diabetes/Metabolic/Endocrinology
Zaltrap ziv-aflibercept 03/08/12 2012 Biologic 1 367 Sanofi (France) Cancer
Juxtapid lomitapide mesylate 21/12/12 2012 NCE 1 1 360 Aegerion (USA) Cardiovascular/Vascular
Stendra Avanafil 27/04/12 2012 NCE 314 Vivus (USA) Urology/Nephrology
Bosulif bosutinib 04/09/12 2012 NCE 1 270 Pfizer (USA) Cancer
Sirturo bedaquiline fumarate 28/12/12 2012 NCE 1 1 1 1 1 258 Johnson & Johnson (USA) Infections bacterial
Zioptan Tafluprost 10/02/12 2012 NCE 250 Merck & Co. (USA) Ophthalmology
Synribo omacetaxine mepesuccinate 26/10/12 2012 NCE 1 1 150 Teva (Israel) Cancer
Fulyzaq crofelemer 31/12/12 2012 NCE 1 1 1 125 Salix Pharmaceuticals (USA) Gastroenterology
Neutroval tbo-filgrastim 29/08/12 2012 Biologic 100 Teva (Israel) Cancer
Surfaxin lucinactant 06/03/12 2012 NCE 1 1 100 Discovery Laboratories (USA) Respiratory
Voraxaze glucarpidase 17/01/12 2012 Biologic 1 1 1 1 25 BTG International (UK) Cancer
Picato ingenol mebutate 23/01/12 2012 NCE 1 n.a. Leo Pharma (Denmark) Dermatology
Sovaldi sofosbuvir 06/12/13 2013 NCE 1 1 1 1 5,650 Gilead Sciences (USA) Infections viral
Imbruvica ibrutinib 13/11/13 2013 NCE 1 1 1 1 1 1 5,250 Johnson & Johnson (USA) Cancer
Kadcyla ado-trastuzumab emtasine 22/02/13 2013 Biologic 1 1 1 3,000 Roche (Switzerland) Cancer
Anoro Ellipta umeclidinum and vilanterol 18/12/13 2013 NCE 2,900 GlaxoSmithKline (UK) Respiratory

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 9
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Tecfidera dimethyl fumarate 27/03/13 2013 NCE 1 2,800 Biogen (USA) Immunology
Breo Ellipta fluticasone furoate; vilanterol 10/05/13 2013 NCE 1,950 GlaxoSmithKline (UK) Respiratory
Gazyva trifenatate
obinutuzumab 01/11/13 2013 Biologic 1 1 1 1,750 Roche (Switzerland) Cancer
Brintellix vortioxetine 30/09/13 2013 NCE 1,750 Takeda (Japan) CNS/Pain/Behaviour
Invokana canagliflozin 29/03/13 2013 NCE 1 1,533 Johnson & Johnson (USA) Diabetes/Metabolic/Endocrinology
Gilotrif afatinib 12/07/13 2013 NCE 1 1 1 1,300 Boehringer Ingelheim (Germany) Cancer
Pomalyst pomalidomide 08/02/13 2013 NCE 1 1 1 1,200 Celgene (USA) Cancer
Tivicay dolutegravir 12/08/13 2013 NCE 1 1 1,150 ViiV Healthcare (UK) Infections viral
Opsumit macitentan 18/10/13 2013 NCE 1 1,043 Actelion (Switzerland) Cardiovascular/Vascular
Xofigo radium RA 223 dichloride 15/05/13 2013 NCE 1 1 1 1,000 Bayer (Germany) Cancer
Adempas riociguat 08/10/13 2013 NCE 1 1 1 803 Bayer (Germany) Cardiovascular/Vascular
Nesina alogliptin benzoate 25/01/13 2013 NCE 800 Takeda (Japan) Diabetes/Metabolic/Endocrinology
Mekinist trametinib 19/05/13 2013 NCE 1 1 1 490 GlaxoSmithKline (UK) Cancer
Olysio simeprevir 22/11/13 2013 NCE 1 1 400 Johnson & Johnson (USA) Infections viral
Olysio simeprevir 22/11/13 2013 NCE 1 1 400 Johnson & Johnson (USA) Infections viral
Kynamro mipomersen sodium 29/01/13 2013 NCE 1 1 400 Sanofi (France) Genetic
Tafinlar dabrafenib 19/05/13 2013 NCE 1 1 350 GlaxoSmithKline (UK) Cancer
Osphena ospemifene 26/02/13 2013 NCE 210 Shionogi (Japan) Women's Health
Duavee conjugated 03/10/13 2013 NCE 200 Pfizer (USA) Women's Health
Aptiom estrogen/bazedoxifene
eslicarbazepine acetate 08/11/13 2013 NCE 90 Dainippon Sumitomo (Japan) CNS/Pain/Behaviour
Luzu luliconazole 14/11/13 2013 NCE n.a. Valeant (Canada) Infections fungal
Harvoni ledipasvir/sofosbuvir 10/10/14 2014 NCE 1 1 1 1 10,000 Gilead Sciences (USA) Infections viral
Opdivo nivolumab 22/12/14 2014 Biologic 1 1 1 1 4,500 Bristol-Myers Squibb (USA) Cancer
Keytruda pembrolizumab 04/09/14 2014 Biologic 1 1 1 1 2,721 Merck & Co. (USA) Cancer
Viekira Pak ombitasvir, paritaprevir, 19/12/14 2014 NCE 1 1 1 1 2,325 AbbVie (USA) Infections viral
Plegridy ritonavir, dasabuvir
peginterferon beta-1a 15/08/14 2014 Biologic 1,828 Biogen (USA) CNS/Pain/Behaviour
Otezla apremilast 21/03/14 2014 NCE 1 1,789 Celgene (USA) Immunology

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 10
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Sylvant siltuximab 23/04/14 2014 Biologic 1 1 1 1,450 Johnson & Johnson (USA) Immunology
Cyramza ramucirumab 21/04/14 2014 Biologic 1 1 1 1,400 Eli Lilly (USA) Cancer
Ofev nintedanib 15/10/14 2014 NCE 1 1 1 1 1,400 Boehringer Ingelheim (Germany) Respiratory
Esbriet pirfenidone 15/10/14 2014 NCE 1 1 1 1 1 1,350 Roche (Switzerland) Respiratory
Zydelig idelalisib 23/07/14 2014 NCE 1 1 1 1 1 1 1,333 Gilead Sciences (USA) Cancer
Trulicity dulaglutide 18/09/14 2014 Biologic 1,270 Eli Lilly (USA) Diabetes/Metabolic/Endocrinology
Farxiga dapaglifozin 08/01/14 2014 NCE 1,233 AstraZeneca (UK) Diabetes/Metabolic/Endocrinology
Entyvio vedolizumab 20/05/14 2014 Biologic 1 1 1,230 Takeda (Japan) Gastroenterology
Zerbaxa ceftolozane/tazobactam 19/12/14 2014 NCE 1 1 1,050 Merck & Co. (USA) Infections bacterial
Vimizim elosulfase alfa 14/02/14 2014 Biologic 1 1 1 1 703 BioMarin (USA) Genetic
Cerdelga eliglustat 19/08/14 2014 NCE 1 1 625 Sanofi (France) Genetic
Lynparza olaparib 19/12/14 2014 NCE 1 1 1 1 553 AstraZeneca (UK) Cancer
Akynzeo netupitant and palonosetron 10/10/14 2014 NCE 515 Eisai (Japan) Cancer
Akynzeo netupitant and palonosetron 10/10/14 2014 NCE 515 Eisai (Japan) Cancer
Belsomra Suvorexant 13/08/14 2014 NCE 1 500 Merck & Co. (USA) CNS/Pain/Behaviour
Sivextro tedizolid phosphate 20/06/14 2014 NCE 1 1 481 Cubist Pharmaceuticals (USA) Infections bacterial
Hetlioz tasimelteon 31/01/14 2014 NCE 1 1 475 Vanda Pharmaceuticals (USA) CNS/Pain/Behaviour
Dalvance dalbavancin 23/05/14 2014 NCE 1 1 1 449 Durata (USA) Infections bacterial
Northera droxidopa 18/02/14 2014 NCE 1 1 1 1 1 444 Chelsea Therapeutics (USA) Cardiovascular/Vascular
Kerydin Tavaborole 07/07/14 2014 NCE 1 436 Anacor Pharmaceuticals (USA) Infections fungal
Jardiance empagliflozin 01/08/14 2014 NCE 421 Eli Lilly (USA) Diabetes/Metabolic/Endocrinology
Tanzeum albiglutide 15/04/14 2014 Biologic 404 GlaxoSmithKline (UK) Diabetes/Metabolic/Endocrinology
Blincyto blinatumomab 03/12/14 2014 Biologic 1 1 1 1 1 375 Amgen (USA) Cancer
Zykadia ceritinib 29/04/14 2014 NCE 1 1 1 1 360 Novartis (Switzerland) Cancer
Zontivity vorapaxar 08/05/14 2014 NCE 1 1 354 Merck & Co. (USA) Cardiovascular/Vascular
Jublia efinaconazole 06/06/14 2014 NCE 350 Valeant (Canada) Infections fungal
Movantik naloxegol 16/09/14 2014 NCE 285 AstraZeneca (UK) Gastroenterology

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 11
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Myalept metreleptin 25/02/14 2014 Biologic 1 1 1 1 225 Bristol-Myers Squibb (USA) Diabetes/Metabolic/Endocrinology
Orbactiv oritavancin 06/08/14 2014 NCE 1 197 Medicines Company (USA) Infections bacterial
Rapivab Peramivir 22/12/14 2014 NCE 1 131 BioCryst Pharmaceuticals (USA) Infections viral
Striverdi Res olodaterol 31/07/14 2014 NCE 61 Boehringer Ingelheim (Germany) Respiratory
Beleodaq belinostat 03/07/14 2014 NCE 1 1 1 1 25 Spectrum Pharmaceuticals (USA) Cancer
Impavido miltefosine 19/03/14 2014 NCE 1 1 1 1 n.a. Knight Therapeutics (Canada) Infections parasitic
Xtoro finafloxacin 17/12/14 2014 NCE 1 n.a. Alcon (Switzerland) Infections bacterial
Entresto sacubitril/valsartan 07/07/15 2015 NCE 1 1 1 6,400 Novartis (Switzerland) Cardiovascular/Vascular
Orkambi lumacaftor 200 mg/ ivacaftor 02/07/15 2015 NCE 1 1 1 1 1 5,200 Vertex Pharmaceuticals (USA) Genetic
Ibrance 125 mg
palbociclib 03/02/15 2015 NCE 1 1 1 1 4,400 Pfizer (USA) Cancer
Praluent alirocumab 24/07/15 2015 Biologic 1 3,500 Sanofi (France) Cardiovascular/Vascular
Repatha evolocumab 27/08/15 2015 Biologic 1 3,150 Amgen (USA) Diabetes/Metabolic/Endocrinology
Tresiba insulin degludec injection 25/09/15 2015 NCE 3,050 Novo Nordisk (Denmark) Diabetes/Metabolic/Endocrinology
Genvoya elvitegravir, cobicistat, 05/11/15 2015 NCE 1 3,000 Gilead Sciences (USA) Infections viral
Darzalex emtricitabine,
daratumumab tenofovir 16/11/15 2015 Biologic 1 1 1 1 1 1 2,450 Johnson & Johnson (USA) Cancer
Tagrisso alafenamide
osimertinib 13/11/15 2015 NCE 1 1 1 1 1 2,400 AstraZeneca (UK) Cancer
Rexulti brexpiprazole 10/07/15 2015 NCE 2,200 Otsuka Pharmaceutical (Japan) CNS/Pain/Behaviour
Alecensa alectinib 11/12/15 2015 NCE 1 1 1 1 1 2,200 Roche (Switzerland) Cancer
Cosentyx secukinumab 21/01/15 2015 Biologic 1 2,000 Novartis (Switzerland) Immunology
Ninlaro ixazomib 20/11/15 2015 NCE 1 1 1,700 Takeda (Japan) Cancer
Uptravi selexipag 22/12/15 2015 NCE 1 1,475 Actelion (Switzerland) Cardiovascular/Vascular
Nucala mepolizumab 04/11/15 2015 Biologic 1 1,250 GlaxoSmithKline (UK) Respiratory
Kanuma sebelipase alfa 08/12/15 2015 Biologic 1 1 1 1 1 1,000 Alexion (USA) Genetic
Daklinza daclatasvir 24/07/15 2015 NCE 1 1 1,000 Bristol-Myers Squibb (USA) Infections viral
Empliciti elotuzumab 30/11/15 2015 Biologic 1 1 1 1 990 Bristol-Myers Squibb (USA) Cancer
Veltassa patiromer for oral suspension 21/01/15 2015 NCE 969 Relypsa (USA) Diabetes/Metabolic/Endocrinology
Aristada aripiprazole lauroxil 06/10/15 2015 NCE 800 Alkermes (USA) CNS/Pain/Behaviour

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 12
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Strensiq asfotase alfa 23/10/15 2015 Biologic 1 1 1 1 1 800 Alexion (USA) Genetic
Avycaz ceftazidime-avibactam 25/02/15 2015 NCE 1 1 1 700 Actavis (Ireland) Infections bacterial
Zurampic lesinurad 22/12/15 2015 NCE 650 AstraZeneca (UK) Diabetes/Metabolic/Endocrinology
Cotellic cobimetinib 10/11/15 2015 NCE 1 1 1 635 Roche (Switzerland) Cancer
Natpara parathyroid horomone 23/01/15 2015 NCE 1 625 Shire (Ireland) Genetic
Odomzo erismodegib 24/07/15 2015 NCE 625 Novartis (Switzerland) Cancer
Cresemba isavuconazonium sulfate 06/03/15 2015 NCE 1 1 1 600 Astellas (Japan) Infections fungal
Portrazza necitumumab 24/11/15 2015 Biologic 1 1 575 Eli Lilly (USA) Cancer
Viberzi eluxadoline 27/05/15 2015 NCE 1 1 570 Allergan (USA) Gastroenterology
Lenvima lenvatinib 13/02/15 2015 NCE 1 1 497 Eisai (Japan) Cancer
Farydak panobinostat 23/02/15 2015 NCE 1 1 1 425 Novartis (Switzerland) Cancer
Kybella deoxycholic acid 29/04/15 2015 NCE 425 Kythera (USA) Dermatology
Varubi rolapitant 02/09/15 2015 NCE 400 Tesaro (USA) Cancer
Vraylar cariprazine 17/09/15 2015 NCE 315 Allergan (USA) CNS/Pain/Behaviour
Corlanor ivabradine 15/04/15 2015 NCE 1 1 1 310 Amgen (USA) Cardiovascular/Vascular
Lonsurf trifluridine and tipiracil 22/09/15 2015 NCE 1 300 Otsuka Pharmaceutical (Japan) Cancer
Kengreal canegrelor 22/06/15 2015 NCE 285 Medicines Company (USA) Cardiovascular/Vascular
Bridion sugammadex sodium 15/12/15 2015 NCE 1 1 270 Merck & Co. (USA) CNS/Pain/Behaviour
Addyi flibanserin 18/08/15 2015 NCE 1 200 Sprout Pharma (USA) Women's Health
Savaysa edoxaban tosylate 08/01/15 2015 NCE 175 Daiichi Sankyo (Japan) Hematology
Unituxin dinutuximab 10/03/15 2015 Biologic 1 1 1 100 United Therapeutics (USA) Cancer
Xuriden uridine triacetate 04/09/15 2015 NCE 1 1 1 1 n.a. Wellstat Therapeutics (USA) Cancer
Yondelis trabectedin 23/10/15 2015 NCE 1 1 n.a. Johnson & Johnson (USA) Cancer
Praxbind idarucizumab 16/10/15 2015 Biologic 1 1 1 1 1 n.a. Boehringer Ingelheim (Germany) Hematology
Cholbam cholic acid 17/03/15 2015 NCE 1 1 n.a. Retrophin (USA) Genetic
Epclusa sofosbuvir and velpatasvir 28/06/16 2016 NCE 1 1 1 5,144 Gilead Sciences (USA) Infections viral
Tecentriq atezolizumab 18/05/16 2016 Biologic 1 1 1 4,629 Roche (Switzerland) Cancer

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 13
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Venclexta venetoclax 29/04/16 2016 NCE 1 1 1 1 1 2,003 Abbvie (USA) Cancer

Xiidra lifitegrast 11/07/16 2016 NCE 1 1 1,880 Shire (Ireland) Ophthalmology
Zepatier elbasvir and grazoprevir 28/01/16 2016 NCE 1 1 1,875 Merck & Co. (USA) Infections viral
Ocaliva obeticholic acid 27/05/16 2016 NCE 1 1 1 1 1 1,768 Intercept (USA) Immunology
Spinraza nusinersen 23/12/16 2016 NCE 1 1 1 1 1,500 Biogen (USA) Genetic
Eucrisa crisaborole 14/12/16 2016 NCE 1 1,372 Pfizer (USA) Dermatology
Nuplazid pimavanserin 29/04/16 2016 NCE 1 1 1,326 Acadia Pharmaceuticals (USA) CNS/Pain/Behaviour
Zinbryta daclizumab 27/05/16 2016 Biologic 1 1,228 Biogen (USA) Immunology
Taltz ixekizumab 22/03/16 2016 Biologic 976 Eli Lilly (USA) Immunology
Adlyxin lixisenatide 27/07/16 2016 NCE 900 Sanofi (France) Diabetes/Metabolic/Endocrinology
Exondys 51 eteplirsen 19/09/16 2016 NCE 1 1 1 1 1 617 Sarepta (USA) Genetic
Rubraca rucaparib 19/12/16 2016 NCE 1 1 1 1 508 Clovis Oncology (USA) Cancer
Lartruvo olaratumab 19/10/16 2016 Biologic 1 1 1 1 1 400 Eli Lilly (USA) Cancer
Cinqair reslizumab 23/03/16 2016 Biologic 300 Teva (Israel) Respiratory
Zinplava bezlotoxumab 21/10/16 2016 Biologic 1 1 1 294 Merck & Co. (USA) Infections bacterial
Defitelio defibrotide sodium 30/03/16 2016 NCE 1 1 1 1 289 Jazz Pharmaceuticals (Ireland) Other
Briviact brivaracetam 18/02/16 2016 NCE 283 UCB (Belgium) CNS/Pain/Behaviour
Dupixent dupilumab 28/03/17 2017 Biologic 1 1 1 6,000 Regeneron / Sanofi (USA) Dermatology

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 14
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Ocrevus ocrelizumab 28/03/17 2017 Biologic 1 1 1 1 4,450 Roche (Switzerland) Immunology

Imfinzi durvalumab 01/05/17 2017 Biologic 1 1 1 3,050 AstraZeneca (UK) Cancer
Ozempic semaglutide 05/12/17 2017 NCE 2,850 Novo Nordisk (Denmark) Diabetes/Metabolic/Endocrinology
Bavencio avelumab 23/03/17 2017 Biologic 1 1 1 1 1 2,800 Pfizer / Merck KgaA (USA) Cancer
Hemlibra emicizumab 16/11/17 2017 Biologic 1 1 1 1 2,150 Roche (Switzerland) Hematology
Yescarta axicabtagene ciloleucel 18/10/17 2017 Biologic 2,000 Gilead Sciences (USA) Cancer
Zejula niraparib 27/03/17 2017 NCE 1 1 1 1 1,850 Tesaro (USA) Cancer
Tremfya guselkumab 13/07/17 2017 Biologic 1,850 Johnson & Johnson (USA) Immunology
Mavyret glecaprevir and pibrentasvir 03/08/17 2017 NCE 1 1 1,675 Abbvie (USA) Infections viral
Kisqali ribociclib 13/03/17 2017 NCE 1 1 1,600 Novartis (Switzerland) Cancer
Nerlynx neratinib maleate 17/07/17 2017 NCE 1,575 Puma Biotechnology (USA) Cancer
Fasenra benralizumab 14/11/17 2017 Biologic 1,550 AstraZeneca (UK) Respiratory
Steglatro ertugliflozin 19/12/17 2017 NCE 1,419 Merck & Co. (USA) Diabetes/Metabolic/Endocrinology
Bevyxxa betrixaban 23/06/17 2017 NCE 1 1 1,375 Portola Pharmaceuticals (USA) Cardiovascular/Vascular
Ingrezza valbenazine 11/04/17 2017 NCE 1 1 1 1,350 Neurocrine Biosciences (USA) CNS/Pain/Behaviour
Kymriah etisagenlecleucel 30/08/17 2017 Biologic 1 1 1,300 Novartis (Switzerland) Cancer
Verzenio abemaciclib 28/09/17 2017 NCE 1 1 1 1,275 Eli Lilly (USA) Cancer
Calquence acalabrutinib 31/10/17 2017 NCE 1 1 1 1 1 1,250 AstraZeneca (UK) Cancer
Shingrix varicella zoster vaccine 20/10/17 2017 Biologic 1,200 GlaxoSmithKline (UK) Infections viral
Besponsa inotuzumab ozogamicin 17/08/17 2017 Biologic 1 1 1 1 1,200 Pfizer (USA) Cancer
Vosevi sofosbuvir, velpatasvir and 18/07/17 2017 NCE 1 1 1 1,100 Gilead Sciences (USA) Infections viral
Kevzara voxilaprevir
sarilumab 22/05/17 2017 Biologic 1,075 Regeneron Pharmaceuticals (USA) Immunology
Alunbrig brigatinib 28/04/17 2017 NCE 1 1 1 1 818 Takeda (Japan) Cancer
Trulance plecanatide 19/01/17 2017 NCE 795 Synergy Pharmaceuticals (USA) Gastroenterology
Austedo deutetrabenazine 03/04/17 2017 NCE 1 750 Teva (Israel) Genetic
Parsabiv etelcalcetide 07/02/17 2017 NCE 600 Amgen (USA) Diabetes/Metabolic/Endocrinology
Giapreza angiotensin II 21/12/17 2017 NCE 1 1 550 La Jolla Pharmaceutical (USA) Intensive care

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 15
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Aliqopa copanlisib 14/09/17 2017 NCE 1 1 1 1 500 Bayer (Germany) Cancer

Idhifa enasidenib 01/08/17 2017 NCE 1 1 1 1 500 Celgene (USA) Cancer
Luxturna voretigene neparvovec-rzyl 19/12/17 2017 Biologic 1 1 1 450 Spark Therapeutics (USA) Genetic
Tymlos abaloparatide 28/04/17 2017 NCE 410 Radius Health (USA) Women's Health
Vabomere meropenem and 29/08/17 2017 NCE 1 1 400 Medicines Company (USA) Infections bacterial
Baxdela vaborbactam
delafloxacin 19/06/17 2017 NCE 1 1 1 400 Melinta Therapeutics (USA) Infections bacterial
Rhopressa netarsudil mesylate 18/12/17 2017 NCE 1 382 Aerie Pharmaceuticals (USA) Ophthalmology
Symproic naldemedine 23/03/17 2017 NCE 250 Shionogi (Japan) Gastroenterology
Prevymis letermovir 08/11/17 2017 NCE 1 1 1 1 1 242 Merck & Co. (USA) Infections viral
Siliq brodalumab 15/02/17 2017 Biologic 240 Valeant (Canada) Immunology
Rydapt midostaurin 28/04/17 2017 NCE 1 1 1 1 1 240 Novartis (Switzerland) Cancer
Brineura cerliponase alfa 27/04/17 2017 Biologic 1 1 1 1 235 Biomarin (USA) Genetic
Vyzulta latanoprostene bunod 02/11/17 2017 NCE 212 Valeant (Canada) Ophthalmology
Radicava ophthalmic
edaravone solution 05/05/17 2017 NCE 1 1 200 Mitsubishi Tanabe (Japan) Genetic
Xermelo telotristat ethyl 28/02/17 2017 NCE 1 1 1 1 196 Lexicon Pharmaceuticals (USA) Cancer

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 16
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Priority Review

Breakthroug D.
Accelerated A.
First in class

Fast Track
FDA Estimated

Orphan
NCE/

QIDP
PRV
Drug Name Active Ingredient Approval Year Peak Sales Sponsor/Owner (Country) Therapeutic Area
Biologic
Date Potential $m

Emflaza deflazacort 09/02/17 2017 NCE 1 1 1 1 150 PTC Therapeutics (USA) Genetic
Rebinyn nonacog beta pegol, N9-GP 31/05/17 2017 Biologic 150 Novo Nordisk (Denmark) Hematology
Odactra Allergen extract 01/03/17 2017 Biologic 140 ALK-Abello (Sweden) Immunology
Solosec secnidazole 15/09/17 2017 NCE 1 1 1 100 Symbiomix (USA) Infections bacterial
Mepsevii vestronidase alfa-vjbk 15/11/17 2017 Biologic 1 1 1 1 71 Ultragenyx (USA) Genetic
Xepi ozenoxacin 11/12/17 2017 NCE 0 n.a. Medimetriks Pharmaceuticals (USA) Infections bacterial
Xadago safinamide 21/03/17 2017 NCE n.a. US WorldMeds (USA) CNS/Pain/Behaviour
Benznidazole benznidazole 29/08/17 2017 NCE 1 1 1 n.a. Insud Pharma (Chemo Group) (SpainInfections parasitic
Biktarvy bictegravir sodium + 07/02/18 2018 NCE 1 6,550 Gilead Sciences (USA) Infections viral
Ultomiris emtricitabine
ravulizumab + tenofovir 21/12/18 2018 Biologic 1 1 2,300 Alexion (USA) Immunology
alafenamide

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 17
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Reyataz HIV-1 infection External

Velcade Multiple myeloma External
Namenda Alzheimer's disease External
Cialis Erectile dysfunction External
Iressa Locally advanced or metastatic non-small ceInhouse
Emend Prevention of nausea and vomiting associa Inhouse
Raptiva Psoriasis External Antibody humanized
Xolair Asthma External Antibody humanized
Amevive Psoriasis Inhouse FusionProtein
Aloxi Prevention of nausea and vomiting associa External
Factive Community acquired pneumonia Inhouse
Plenaxis Advanced symptomatic prostate cancer Inhouse Peptide
Levitra Erectile dysfunction Inhouse
Somavert Acromegaly M&A Protein
Crestor Hypercholesterolemia External
Boniva Treatment and prevention of postmenopausaInhouse
Zavesca Gaucher's disease External
Ertaczo Interdigital tenea pedis in immunocompetentExternal
Aldurazyme Pucopolysaccharidosis-I (MPS-I) External Enzyme
Fabrazyme Fabry Disease Inhouse Enzyme
Emtriva HIV-1 infection External
Elestat Itching asscociated with allergic conjunctivit External
Cubicin Skin infections by gram positive microorgan External
Fuzeon HIV-1 infection External Peptide
Uroxatral Benign prostatic hyperplasia Inhouse
Alimta Malignant pleural mesothelioma Inhouse
Lyrica Neuropathic pain Inhouse

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 18
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Tarceva Metastatic non small-cell lung cancer (NSCLC External

Erbitux EGFR-expressing metastatic colorectal can Inhouse Antibody chimeric
Tysabri Relapsing forms of Multiple Sclerosis External Antibody humanized
Clolar Acute lymphoblastic leukemia M&A
Apidra Diabetes type 1 and 2 Inhouse Peptide
Apokyn Parkinson's disease External
Ketek Various bacterial infections Inhouse
Sensipar Secondary hyperparathyroidism, hypercalc External
Cymbalta Depression Inhouse
Campral Alcohol abuse External
Nutrestore Gastrointestinal cell growth, function and re Inhouse
Sanctura Overactive bladder External
Vidaza Acute myeloid leukemia External
Spiriva COPD, chronic bronchitis and emphysema Inhouse
Xifaxan (NormTraveler's diarrhea External
Macugen Macular Edema, wet age-related macular deExternal
Fosrenol Hyperphosphatemia in patients with end staExternal
Omacor Prevention therapy after myocardial infarcti External
Vesicare Overactive bladder Inhouse
Lunesta Insomnia External
Enablex Overactive bladder External
Prialt Severe chronic pain M&A Peptide
Tindamax Protozoan infections Inhouse
Kepivance Cancer induced oral mucositis Inhouse Protein
Ventavis Pulmonary arterial hypertension External
Avastin Metastatic colorectal cancer Inhouse Antibody humanized
Revlimid Transfusion dependent anemia Inhouse

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 19
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Byetta Diabetes type 2 Inhouse Peptide

Orencia Moderate to severe rheumatoid arthrits Inhouse FusionProtein
Baraclude Chronic hepatitis B infection Inhouse
Levemir Diabetes type 1 and 2 Inhouse Peptide
Exjade Chronic iron overload due to blood transfusiInhouse
Nexavar Advanced renal cell carcinoma Inhouse
Tygacil Bacterial skin infections and intraabdominal Inhouse
Iplex Growth failure in children M&A FusionProtein
Symlin Diabetes type 1 and 2 Inhouse Peptide
Increlex Growth failure in children External
Vaprisol Euvolemic hyponatremia Inhouse
Arranon T-cell lymphoblastic leukemia, T-cell lymph Inhouse
Nevanac Pain and inflammation associated with catarExternal
Rozerem Insomnia Inhouse
Aptivus HIV-1 infection External
Naglazyme Mucopolysaccharidosis VI storage disordersInhouse Enzyme
Mycamine Candida albicans infection Inhouse
Januvia Diabetes type 2 Inhouse
Lucentis Age-related macular degeneration Inhouse Antibody humanized
Sprycel Chronic myeloid leukemia Inhouse
Sutent Renal cell carcinoma, gastrointestinal stromM&A
Invega Schizophrenia Inhouse
Myozyme Pompe disease Inhouse Enzyme
Chantix Nicotine abuse Inhouse
Elaprase Hunter Syndrome (Muccopolysaccharidosis)M&A Enzyme
Azilect Parkinsons' disease Inhouse
Ranexa Angina pectoris External

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 20
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Vectibix EGFR-expressing metastatic colorectal car M&A Antibody human

Prezista HIV-1 infection M&A
Zolinza Non-Hodkin lymphoma (Cutaneous T-cell l External
Eraxis Candidia fungal infections External
Dacogen Myelodysplastic syndrome External
Noxafil Prophylaxis of invasive Aspergillus and CandInhouse
Amitiza Chronic idiopathic constipation Inhouse
Pylera H. Pylori infection Inhouse
Omnaris Allergic rhinitis Inhouse
Tyzeka Chronic hepatitis B infection External
Veregen Genital warts External
Isentress HIV-1 infection Inhouse
Tasigna Philadelphia chromosome positive chronic Inhouse
Vyvanse Attention-Deficit/Hyperactivity Disorder (AD M&A
Tekturna Hypertension Inhouse
Mircera Anemia associated with chronic renal failureInhouse Protein
Bystolic Hypertension External
Letairis Pulmonary arterial hypertension External
Tykerb Advanced or metastatic breast cancer Inhouse
Neupro Early stage idiopathic parkinson's disease M&A
Torisel Advanced renal cell carcinoma Inhouse
Doribax Complicated intra-abdominal & urinary tract External
Somatuline deAcromegaly Inhouse Peptide
Altabax Impetigo Inhouse
Selzentry HIV-1 infection Inhouse
Ixempra Metastatic breast cancer Inhouse
Kuvan Phenylketonuria External

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 21
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Soliris Hemolytic-uremic syndrome Inhouse Antibody humanized

Vimpat Partial-onset seizures in patients with epilepM&A
Treanda Chronic lymphocytic leukemia External
Cimzia Crohn's disease M&A Antibody humanized
Relistor Opioid-induced constipation External
Pristiq Antidepressant Inhouse
Intelence HIV-1 infection M&A
Nplate Thrombocytopenia in patients with chronic Inhouse FusionProtein
Toviaz Overactive bladder External
Nucynta Moderate to severe pain External
Entereg Upper and lower gastrointestinal recovery f External
Xenazine Chorea Huntington's disease External
Mozobil Non-Hodgkin Lymphoma, multiple myelomaM&A
Cleviprex Hypertension External
Arcalyst Cryopyrin-associated periodic syndrome (C Inhouse FusionProtein
Promacta Thrombocytopenia in patients with chronic External
Firmagon Advanced prostate cancer Inhouse Peptide
Lusedra Sedation in adult patients undergoing diagnoM&A
Durezol Inflammation and pain associcated with oculExternal
Banzel Lennox-Gastaux Syndrome (LGS) External
Rapaflo Benign prostatic hyperplasia External
Simponi Rheumatoid arthritis, psoriatic arthritis, ankyInhouse Antibody human
Afinitor Advanced renal cell carcinoma Inhouse
Multaq Atrial fibrillation Inhouse
Saphris Schizophrenia M&A
Stelara Moderate to severe psoriasis M&A Antibody human
Onglyza Diabetes type 2 Inhouse

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 22
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Effient Thrombotic cardiovascular events External

Livalo Hypercholesterolemia External
Votrient Renal cell carcinoma Inhouse
Arzerra Chronic lymphocytic leukemia External Antibody human
Ilaris Cryopyrin-associated periodic syndrome (C Inhouse Antibody human
Uloric Hyperuricemia in patients with gout External
Savella Fribromyalgia External
Istodax Non-Hodkin Lymphoma (Cutaneous T-cell External
Vibativ Gram positive bacterial skin infection Inhouse
Sabril Infantile spasm (West Syndrome) External
Besivance Conjunctivitis External
Kalbitor Hereditary angiodema Inhouse Peptide
Ulesfia Head lice infestation External
Bepreve Ocular itching associated with allergic conjunExternal
Samsca Hyponatremia (low blood sodium) Inhouse
Coartem Acute, uncomplicated malaria infections Inhouse
Dysport Cervical dystonia, glabellar lines Inhouse Protein
Qutenza Neuropathic pain associated with neuralgia Inhouse
Folotyn Relapsed or refractory peripheral T-cell l Inhouse
Fanapt Schizophrenia External
Gilenya Relapsing forms of Multiple Sclerosis External
Victoza Diabetes type 2 External Peptide
Actemra Rheumatoid arthritis External Antibody humanized
Pradaxa Anticoagulant to reduce risk of stroke and blInhouse
Lumizyme Pompe disease Inhouse Enzyme
Prolia Osteoporosis Inhouse Antibody human
Jevtana Kit Metastatic prostate cancer Inhouse

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 23
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Halaven Metastatic breast cancer Inhouse

Natazia Contraception M&A
Krystexxa Chronic gout in adults Inhouse Enzyme
Latuda Schizophrenia Inhouse
Xiaflex Morbus Dupuytren Inhouse Enzyme
Ampyra Improvement of walking in mulitple sclerosisExternal
Egrifta HIV-asscociated lipodystrophy Inhouse Peptide
Vpriv Type 1 Gaucher disease Inhouse Enzyme
Teflaro Acute bacterial skin/skin structure infecti External
Ella Emergency contraception Inhouse
Lastacaft Allergic conjunctivits Inhouse
Asclera Small varicose veins M&A
Carbaglu N-acetylglutamate synthase deficiency M&A
Xeomin Cervical dystonia and blepharospasm M&A Protein
Incivek Chronic hepatitis C infection Inhouse
Eylea Age-related macular degeneration Inhouse FusionProtein
Victrelis Chronic hepatitis C infection M&A
Yervoy Metastatic melanoma in late stage skin cancExternal Antibody human
Xarelto Anticoagulant after knee or hip replacementExternal
Brilinta Acute coronary syndroms Inhouse
Zytiga Metastatic castration resistant prostate can External
Tradjenta Diabetes type 2 Inhouse
Benlysta Lupus erythematosus Inhouse Antibody human
Xalkori Late stage non-small cell lung cancer (NSC Inhouse
Zelboraf BRAF mutation positive cancers External
Adcetris Hodgkin lymphoma after failure of autologouInhouse Antibody chimeric
Potiga Seizures associated with epilepsy in adults External

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 24
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Edarbi Hypertension Inhouse

Arcapta NeohaChronic obstructive pulmonary disease (C Inhouse
Edurant HIV-1 infection M&A
Jakafi Myelofibrosis Inhouse
Nulojix Kidney transplant rejection Inhouse FusionProtein
Ferriprox Thalassemia Inhouse
Viibryd Antidepressant External
Erwinaze Lymphoblastic leukemia M&A Enzyme
Firazyr Acute attacks of hereditary angiodema M&A
Onfi Lennox-Gastaux Syndrome (LGS) Inhouse
Dificid Clostridium difficile diarrhea Inhouse
Daliresp Chronic obstructive pulmonary disease (C External
Caprelsa Medullary thyroid cancer Inhouse
Horizant Restless legs syndrome External
Natroba Head lice infestations Inhouse
Eliquis Prevention/treatment of venous thromboemboli Inhouse
Xeljanz Rheumatoid arthritis Inhouse
Xtandi Metastatic castration resistant prostate cancInhouse
Belviq Obesity Inhouse
Perjeta Metastatic breast cancer M&A Antibody humanized
Kalydeco Cystic fibrosis Inhouse
Stribild HIV-1 infection External
Kyprolis Multiple myeloma M&A
Erivedge Advanced basal cell carcinoma External
Fycompa Partial-onset seizures in patients with epilepInhouse
Jetrea Age-related macular degeneration Inhouse Enzyme
Iclusig Chronic myeloid leukemia Inhouse

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 25
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Linzess Constipation, irritable bowel syndrome External

Cometriq Progressive, metastatic medullary thyroid c Inhouse
Aubagio Relapsing forms of multiple Sclerosis Inhouse
Myrbetriq Overactive bladder Inhouse
Omontys Anemia in chronic kidney disease patients onInhouse Peptide
Stivarga Metastatic colorectal cancer Inhouse
Tudorza PressLong term maintenance treatment of bron External
Inlyta Advanced renal cell carcinoma Inhouse
Elelyso Type 1 Gaucher disease External
Gattex Kit Short bowel syndrome M&A Peptide
Signifor Cushing's syndrome Inhouse
Zaltrap Metastatic colorectal cancer Inhouse FusionProtein
Juxtapid Hypercholesterolemia External
Stendra Erectile dysfunction Inhouse
Bosulif Chronic myelogenous leukemia M&A
Sirturo Tuberculosis Inhouse
Zioptan Reduction of intraocular pressure (IOP), gl External
Synribo Chronic myeloid leukemia M&A
Fulyzaq Chronic diarrhea asscociated with AIDS External
Neutroval Neutropenia in chemotherapy patients External Protein
Surfaxin Prevention of respiratory distress syndrome Inhouse
Voraxaze Toxic methotrexate concentrations in plasm Inhouse Enzyme
Picato Actinic keratosis M&A
Sovaldi Hepatitis C virus (HCV) infection M&A
Imbruvica Mantle Cell Lymphoma (MCL) External
Kadcyla Metastatic breast cancer M&A Antibody conjugate
Anoro Ellipta Chronic obstructive pulmonary disease (COExternal

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 26
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Tecfidera Relapsing forms of Multiple Sclerosis External

Breo Ellipta Chronic obstructive pulmonary disease (COExternal
Gazyva Chronic lymphocytic leukemia (CLL) M&A Antibody humanized
Brintellix Major depressive disorder External
Invokana Diabetes type 2 External
Gilotrif Late stage (metastatic) non-small cell lung Inhouse
Pomalyst Multiple myeloma Inhouse
Tivicay HIV-1 infection Inhouse
Opsumit Pulmonary arterial hypertension (PAH) Inhouse
Xofigo Metastatic castration-resistant prostate cancExternal
Adempas Pulmonary arterial hypertension (PAH) Inhouse
Nesina Diabetes type 2 Inhouse
Mekinist Metastatic melanoma External
Olysio Hepatitis C virus (HCV) infection External
Olysio Hepatitis C virus (HCV) infection External
Kynamro Homozygous/heterozygous familial hyperchoExternal Other (antisense oligonuc
Tafinlar Metastatic melanoma Inhouse
Osphena Dyspareunia M&A
Duavee Hot flashes (vasomotor symptoms) and osteM&A
Aptiom Seizures associated with epilepsy. External
Luzu Tinea pedis, tinea cruris and tinea corporis M&A
Harvoni Hepatitis C (HCV) genotype 1 infection Inhouse
Opdivo Melanoma metastatic External Antibody human
Keytruda Advanced or unresectable melanoma M&A Antibody humanized
Viekira Pak Chronic hepatitis C virus (HCV) genotype 1 iI nhouse
Plegridy Relapsing multiple sclerosis Inhouse Protein
Otezla Psoriatic arthritis Inhouse

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 27
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Sylvant Castleman’s disease (MCD) Inhouse Antibody chimeric

Cyramza Advanced stomach cancer or gastroesophagM&A Antibody human
Ofev Idiopathic pulmonary fibrosis (IPF) Inhouse
Esbriet Idiopathic pulmonary fibrosis (IPF) M&A
Zydelig Chronic lymphocytic leukemia (CLL) M&A
Trulicity Type 2 diabetes Inhouse FusionProtein
Farxiga Diabetes type 2 External
Entyvio Ulcerative colitis, Crohn‘s disease. M&A Antibody humanized
Zerbaxa Intra-abdominal und urinary tract infections External
Vimizim Mucopolysaccharidosis Type IVA (Morquio Inhouse Enzyme
Cerdelga Gaucher disease type 1 M&A
Lynparza Advanced ovarian cancer associated with d M&A
Akynzeo Nausea and vomiting (cancer chemotherapyExternal
Akynzeo Nausea and vomiting (cancer chemotherapyExternal
Belsomra Insomnia Inhouse
Sivextro Acute bacterial skin and skin structure_x000D_
M&A
Hetlioz infections (ABSSSI)
Non-24 hour sleep-wake disorder External
Dalvance Acute bacterial skin and skin structure infe M&A
Northera Neurogenic orthostatic hypotension (NOH) External
Kerydin Onychomycosis of the toenails Inhouse
Jardiance Diabetes type 2 External
Tanzeum Diabetes type 2 External FusionProtein
Blincyto Acute lymphoblastic leukemia M&A Antibody bispecific
Zykadia Metastatic non-small cell lung cancer (NSC Inhouse
Zontivity Reduce the risk of heart attack, stroke, car M&A
Jublia Onychomycosis M&A
Movantik Opioid-induced constipation External

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 28
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Myalept Generalized lipodystrophy, leptin replacemeM&A Protein

Orbactiv Acute bacterial skin and skin structure infe External
Rapivab Influenza infections External
Striverdi Res Chronic obstructive pulmonary disease (COPD Inhouse
Beleodaq Peripheral T-cell lymphoma (PTCL) External
Impavido Leishmaniasis External
Xtoro Acute otitis externa, commonly known as s External
Entresto Heart failure Inhouse
Orkambi Cystic fibrosis Inhouse
Ibrance Advanced metastatic breast cancer External
Praluent High cholesterol External Antibody human
Repatha Cholesterol-lowering medication Inhouse Antibody human
Tresiba Improve blood suagr (glucose) control in aduInhouse Peptide
Genvoya HIV-1 infection Inhouse
Darzalex Multiple myeloma External Bi-specific antibody
Tagrisso Non-small cell lung cancer Inhouse
Rexulti Schizophrenia, major depressive disorder Inhouse
Alecensa ALK-positive lung cancer External
Cosentyx Moderate-to-severe plaque psoriasis Inhouse Antibody human
Ninlaro Multiple myeloma M&A
Uptravi Pulmonary arterial hypertension External
Nucala Asthma maintenance treatment Inhouse Antibody humanized
Kanuma Lysosomal acid lipase (LAL) deficiency M&A Enzyme
Daklinza Chronic hepatitis C virus (HCV) genotype 3 iI nhouse
Empliciti Multiple myeloma M&A Antibody humanized
Veltassa Hyperkalemia( elevated potassium) Inhouse
Aristada Schizophrenia Inhouse

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 29
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Strensiq Perinatal, infantile and juvenile-onset hyp M&A Enzyme

Avycaz Intra-abdominal infections (cIAI), complicatedM&A
Zurampic High blood uric acid levels associated with M&A
Cotellic Advanced melanoma (BRAF V600E or V600K External
Natpara Control hypocalcemia (low blood calcium levM&A Peptide
Odomzo Advanced basal cell carcinoma Inhouse
Cresemba Invasive aspergillosis and invasive mucorm External
Portrazza Advanced (metastatic) squamous non-smallM&A ce Antibody human
Viberzi Irritable bowel syndrome with diarrhea (IBS-External
Lenvima Progressive, differentiated thyroid cancer ( Inhouse
Farydak Multiple myeloma Inhouse
Kybella Moderate-to-severe fat below the chin Inhouse
Varubi Chemotherapy-induced nausea and vomitingExternal
Vraylar Schizophrenia and bipolar disorder External
Corlanor Reduce hospitalization from worsening heartExternal
Lonsurf Colorectal cancer Inhouse
Kengreal Anticoagolant External
Bridion Reverse effects of neuromuscular blocking M&A
Addyi Hypoactive sexual desire disorder (HSDD) Inhouse
Savaysa Reduce the risk of stroke and systemic embInhouse
Unituxin High-risk neuroblastoma (pediatric) Inhouse Antibody chimeric
Xuriden Emergency treatment overdose from chemoInhouse
Yondelis Soft tissue sarcomas, liposarcoma and lei External
Praxbind Reverse Pradaxa’s blood-thinning effects. Inhouse Antibody human (fragmen
Cholbam Bile acid synthesis disorders due to single M&A
Epclusa Chronic hepatitis C virus (HCV) genotype 1,Inhouse
2
Tecentriq Urothelial carcinoma Inhouse Antibody human

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 30
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Venclexta Chronic lymphocytic leukemia (CLL) Inhouse

Xiidra Dry eye disease M&A
Zepatier Hepatitis C Virus Genotype 1 and 4 Inhouse
Ocaliva Primary biliary cholangitis (PBC) Inhouse
Spinraza Spinal muscular atrophy (SMA) External
Eucrisa Mild to moderate atopic dermatitis M&A
Nuplazid Hallucinations and delusions associated wit Inhouse
Zinbryta Relapsing remitting multiple sclerosis External Antibody humanized
Taltz Moderate-to-severe plaque psoriasis Inhouse Antibody humanized
Adlyxin Glycemic control in diabetes type 2 External Peptide
Exondys 51 Duchenne muscular dystrophy Inhouse
Rubraca Ovarian cancer with BRCA mutations External
Lartruvo Soft tissue sarcoma M&A Antibody human
Cinqair Severe asthma M&A Antibody humanized
Zinplava Recurrent Clostridium difficile infection External Antibody human
Defitelio Hepatic veno-occlusive disease after hematopM&A
Briviact Partial onset seizures in epilepsy Inhouse
Dupixent Moderate-to-severe atopic dermatitis Inhouse Antibody human

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 31
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Ocrevus Relapsing and primary progressive multiple External Antibody humanized

Imfinzi Advanced or metastatic urothelial carcinom M&A Antibody human
Ozempic Diabetes type 2 Inhouse Peptide
Bavencio Merkel cell carcinoma Inhouse Antibody human
Hemlibra Hemophilia A External Antibody bispecific
Yescarta Large B-cell lymphoma M&A T cell therapy
Zejula Recurrent epithelial ovarian/fallopian tube/p External
Tremfya Moderate-to-severe plaque psoriasis M&A Antibody human
Mavyret Hepatitis c Inhouse
Kisqali Advanced or metastatic breast cancer External
Nerlynx Adjuvant treatment HER2-positive breast caExternal
Fasenra Severe Asthma M&A Antibody
Steglatro Diabetes type 2 External
Bevyxxa Prophylaxis of venous thromboembolism (V External
Ingrezza Tardive dyskinesia Inhouse
Kymriah Acute Lymphoblastic Leukemia External Cell-based gene therapy
Verzenio Advanced or metastatic breast cancer Inhouse
Calquence Mantle cell lymphoma M&A
Shingrix Prevention of herpes zoster Inhouse Vaccine
Besponsa Acute lymphoblastic leukemia External Antibody humanized
Vosevi Hepatitis C Inhouse
Kevzara Moderate to severe rheumatoid arthritis Inhouse Antibody human
Alunbrig ALK-positive metastatic non-small cell lun M&A
Trulance Chronic idiopathic constipation M&A Peptide
Austedo Huntington chorea M&A
Parsabiv Secondary Hyperparathyroidism M&A Peptide
Giapreza Septic shock Inhouse Peptide

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 32
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Aliqopa Follicular lymphoma Inhouse

Idhifa Acute myeloid leukemia External
Luxturna RPE65 mutation-associated retinal dystrophInhouse Gene therapy
Tymlos Osteoporosis in postmenopausal women External Peptide
Vabomere Complicated urinary tract infections M&A
Baxdela Acute bacterial skin infections External
Rhopressa Glaucoma Inhouse
Symproic Opioid-induced constipation Inhouse
Prevymis CMV infections prevention External
Siliq Moderate-to-severe plaque psoriasis External Antibody human
Rydapt Acute myeloid leukemia (AML) Inhouse
Brineura Infantile neuronal ceroid lipofuscinosis type Inhouse Enzyme
Vyzulta Open-angle glaucoma; ocular hypertension External
Radicava Amyotrophic lateral sclerosis (ALS) Inhouse
Xermelo Carcinoid syndrome diarrhea Inhouse

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 33
HBM New Drug Approval Database (sorted by year and by peak sales potential) New Molecular Entities (NMEs) approved by FDA

Type of Molecule
Inhouse/
Drug Name Indication (biologics and other
External
large molecules)

Emflaza Duchenne muscular dystrophy (DMD) External

Rebinyn Hemophilia B Inhouse Protein recombinant
Odactra House dust mice allergy Inhouse Extract
Solosec Bacterial vaginosis Inhouse
Mepsevii Mucopolysaccharidosis type VII (Sly syndro Inhouse Enzyme
Xepi Bacterial skin infections (impetigo) External
Xadago Parkinsons add-on treatment External
Benznidazole Chagas disease Inhouse
Biktarvy HIV Inhouse
Ultomiris Paroxysmal nocturnal hemoglobinuria (PNHInhouse Antibody humanized

09/01/2019 / CBER NMEs only for 2017 2018, do not include

Peak all
sales
CBER
estimates
approved
onlyproducts!
complete for 2010ff / External = US or worldwide license, complex cases simplyfied! Page 34