280401

This Professional Resource gives subscribers
additional insight related to the Recommendations published in
PHARMACISTS LETTER / PRESCRIBERS LETTER

September 2016 ~ Resource #320947
Anticipated Availability of First-Time Generics

To help explain the benefits of generic drugs to your patients, the FDA has patient education materials available at
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/default.htm
Branda
(Manufacturer)
Generic Name
Generic Manufacturer(s)b,1
Anticipated Availabilityc
Ammonul
(Medicis)
Asacol HD
(Warner Chilcott)
Cordran SP
(Aqua)
Crestor
(AstraZeneca)
Delalutin
(Bristol-Myers Squibb)
Diabeta
(Sanofi Aventis)
Doryx
(Mayne)
Enablex
(Novartis)
Exelon
(Novartis)
Fenoglide
(Santarus)
Frova
(Endo)
Fusilev
(Spectrum)
Sodium benzoate/Sodium
phenylacetate
Mesalamine delayed-release tablet
Trigen (Ailex)
Generic now available
Zydus
Flurandrenolide 0.05% cream
Cintex (Teligent)
Generic now available (authorized

generic)
Rosuvastatin calcium
Apotex, Avkare (Par), Citron (Aurobindo),

Glenmark, Mylan, Par, Sandoz, Sun, Teva
ANI Pharmaceuticals (McGuff/Aspen)
Impax (CorePharma)
Doxycycline hyclate delayedrelease tablet 50 mg, 200 mg

Darifenacin
Mylan
Par (Anchen), Teva
Rivastigmine transdermal patch
Alvogen
Fenofibrate tablet 40 mg, 120 mg
Mylan
Frovatriptan
Glenmark, Mylan, Par
Levoleucovorin 50 mg/vial
West-Ward (Eurohealth)
Hydroxyprogesterone caproate
injection (brand discontinued)
Glyburide
More. . .
Copyright 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
PharmacistsLetter.com ~ PrescribersLetter.com ~ PharmacyTechniciansLetter.com ~ NursesLetter.com
(Professional Resource #320947: Page 2 of 21)
Branda
(Manufacturer)
Generic Name
Gleevec
(Novartis)
Glumetza
(Santarus)
Glyset
(Pharmacia & Upjohn)
Imitrex
(GlaxoSmithKline)
Integrilin
(Schering)
Intermezzo
(Purdue)
Lodosyn
(Aton)
Naftin
(Merz)
Nasonex
(Merck)
Neoprofen
(Recordati Rare)
Nilandron
(Concordia)
Nuvigil
(Teva)
Oxistat
(Fougera)
Tikosyn
(Pfizer)
Trizivir
(GlaxoSmithKline)
Voltaren
(GlaxoSmithKline)
Imatinib
Apotex, Sun, Teva
Metformin extended-release tablet
Lupin
Miglitol tablets
Sun (Orient)
Sumatriptan nasal spray
Lannett
Eptifibatide
AuroMedics (Aurobindo), Teva
Zolpidem sublingual tablet
Gavis (Novel)
Carbidopa
Naftifine 2% cream
Alvogen, Avkare (Alvogen), Amerigen,

Edenbridge
Taro
Mometasone nasal spray
Apotex
Ibuprofen lysine
X-Gen (Exela)
Nilutamide
ANI Pharmaceuticals
Armodafinil
Mylan
Oxiconazole 1% cream
Taro
Dofetilide
Mayne (Tiger)
Abacavir, lamivudine, zidovudine
Lupin
Diclofenac 1% gel
Amneal
More. . .
Branda
(Manufacturer)
Generic Name
Zegerid
(Santarus)
Zegerid OTC
(Bayer)
Ziana
(Medicis)
Cubicin
(Cubist)
Edecrin
(Aton)
Epzicom
(GlaxoSmithKline)
Zegerid
(Santarus)
Remicade
(Janssen)
Azor
(Daiichi Sankyo)
Benicar/Benicar HCT
(Daiichi Sankyo)
Omeprazole/Sodium bicarbonate
capsule
capsule
Clindamycin phosphate 1.2%/
Tretinoin 0.025%
Daptomycin
Ajanta, Dr. Reddys, Northstar Rx (Ajanta),

Par
Perrigo (CVS, Walgreens)
Teva (Actavis)
Crane, Hospira, Teva
2nd half of 201619
Ethacrynic acid 25 mg tablet
Edenbridge
2nd half of 2016153
Abacavir sulfate/Lamivudine
600 mg/300 mg tablet
suspension
Infliximab
Aurobindo, Cipla, Hetero, Matrix, Mylan,

Teva
Ajanta
September 201690
Hospira (biosimilari)
4th quarter 2016143
Olmesartan/Amlodipine
Macleods, Matrix, Teva, Torrent
October 2016
Olmesartan/Olmesartan HCTZ
Olmesartan: Alembic, Alkem, Amneal,

Aurobindo, Glenmark, Jubilant, Macleods,
Mylan, Sandoz, Sciegen, Teva, Torrent
Olmesartan HCTZ: Aurobindo, Macleods,
Mylan, Prinston, Teva
Accord, Handa, Mylan
October 201624
Seroquel XR
(AstraZeneca)
Kaletra
(Abbott)
Lantus
(Sanofi-Aventis)
Quetiapine extended-release tablet

Lopinavir/Ritonavir
Insulin glargine
Tablet: Aurobindo, Cipla, Hetero, Matrix,

Macleods, Mylan
Oral solution: Cipla
Eli Lilly/Boehringer Ingelheim
2nd half of 201647
November 20162
December 20169,36,137
December 2016109 (This product
will be a new brand of insulin
glargine [Basaglar], not a generic.)
More. . .

Branda
(Manufacturer)
Generic Name
Norvir
(Abbvie)
ProAir HFA
(Teva)
Relpax
(Pfizer)
Aggrenox
(Boehringer Ingelheim)
Azilect
(Teva)
Tamiflu
(Genentech)
Minastrin 24 Fe
(Warner Chilcott)
Pristiq
(Wyeth)
Vytorin
(Merck)
Zetia
(Merck)
Strattera
(Lilly)
Adcirca
(Lilly)
Prezista
(Janssen)
Reyataz
Sustiva
Ritonavir 100 mg tablet
Aurobindo, Cipla, Mylan, Hetero,h,73 Roxane
December 20169,137
Albuterol
Perrigof,34
December 201634
Eletriptan
Ajanta, Apotex, Mylan, Teva
December 201624
Aspirin/Dipyridamole
Teva
Rasagiline mesylate tablet
Alkem, Apotex, Mylan, Orchid, Sandoz,f,30
January 2017 (note: authorized

generics now available)
February 201730
Oseltamivir capsules
Natco
Before February 2017139
Ethinyl estradiol/Norethindrone
acetate/Ferrous fumarate
Desvenlafaxine succinate
extended-release tablet
Ezetimibe/Simvastatin
Lupin
March 2017151
Actavis, Alembic, Mylan, Lupin, Roxane,

Sandoz
Impax, Mylan, Tevaf,134
March 201733
Ezetimibe
Actavis, Mylan, Sandoz, Teva
April 201712,140
Atomoxetine
May 2017
Tadalafil
Apotex, Aurobindo, Dr. Reddys, Glenmark,

Hetero, Mylan, Sandoz, Sun, Zydus
Aurobindo, Synthon
November 201718
Darunavir tablet
Hetero, Lupin, Mylan, Teva
November 201779
Atazanavir
Aurobindo, Emcure, Matrix, Teva
December 201752
Efavirenz
Tablet: Aurobindo, Cipla, Emcure, Hetero,

Macleods, Matrix, Micro Labs, Mylan, Par,
Strides
Capsule: Aurobindo, Cipla, Micro Labs
December 201724
April 201728,134
More. . .
Branda
(Manufacturer)
Generic Name
Truvada
(Gilead)
Viagra
(Pfizer)
Emtricitabine/Tenofovir
disoproxil fumarate tablet
Sildenafil
December 201725
Viread
(Gilead)
Copaxone
(Teva)
Solodyn
(Medicis)
Tenofovir disoproxil fumarate

tablet
Glatiramer 40 mg/mL
Aurobindo, Cipla, Hetero, Lupin,f,25 Matrix,

Mylan,f,25 Strides Arcolab, Teva
Actavis, Ajanta, Amneal, Apotex, Aurobindo,
Dr. Reddys, Hetero, Macleods, Mylan,
Rubicon
Aurobindo, Cipla, InvaGen, Lupin, Macleods,
Matrix, Mylan, Strides Arcolab, Teva
Dr. Reddys,h,94 Mylan,h,146
Momenta/Novartis,h,146 Sandozh,70
Apotex,h,117 Aurobindo, Mylan, Sandoz,
Sidmak, Sun, Teva
Treximet
(Pozen)
Factive
(Cornerstone)
Sensipar
(Amgen)
Enbrel
(Amgen)
Lexiva
(Vertex)
Remodulin
(United Therapeutics)
Acanya
(Valeant)
Clolar
(Genzyme)
Emend
(Merck)
Latuda
(Sunovion)
Minocycline extended-release
tablet 55 mg, 65 mg, 80 mg,
105 mg, 115 mg
Sumatriptan/Naproxen
December 2017 (or earlier)91,92

December 20178
First half 2018146
February 201824
Gemifloxacin tablet
Alphapharm,f,102 Dr. Reddys, Mylan, Par,

Tevaf,102
Orchid
February 2018102
March 201829
Cinacalcet tablet
Actavis, Mylan, Teva
March 201851
Etanercept
Sandoz (biosimilar1)
April 2018 or later159
Fosamprenavir
Lupin, Mylan
June 2018d,130
Treprostinil injection
Sandoz
June 2018 (or earlier)126
Benzoyl peroxide 2.5%/

Clindamycin phosphate 1.2%
Clofarabine
Actavis
July 2018 (or earlier)87
Abon,h,142 Sun,h,101 Zydus
July 2018d
Aprepitant capsule
Sandoz
July 2018e,113
Lurasidone
Amneal, Emcure, InvaGen,h,135 Lupin, MSN,

Sun
July 2018d
More. . .

Branda
(Manufacturer)
Generic Name
Atripla
(Gilead)
Aloxi
(Eisai)
Levitra
(GlaxoSmithKline)
Vesicare
(Astellas)
Finacea
(Bayer)
Fortesta
(Endo)
Lyrica
(Pfizer)
Efavirenz/Emtricitabine/Tenofovir
disoproxil fumarate
Palonosetron injection
August 2018e,68
Vardenafil tablet
Aurobindo, Cipla, Hetero, Macleods, Matrix,

Teva
Akorn, Aurobindo, Dr. Reddys, Exela,
Fresenius Kabi, Sandoz, Teva
Macleods, Teva
Solifenacin succinate
Actavis, Teva
October 201820
Azelaic acid
Glenmark
November 2018
Testosterone gel
Actavis
November 2018d,65
Pregabalin
December 201850
Zyclara
(Medicis)
Ranexa
(Gilead)
AzaSite
(InSite Vision)
Emend
(Merck)
Faslodex
(AstraZeneca)
Exjade
(Novartis)
Sporanox
(Janssen)
Imiquimod cream
Capsule: Actavis, Alembic, Apotex,

Aurobindo, Lupin, Macleods, Mylan, Sandoz,
Teva, Wockhardt
Oral solution: Apotex, Lupin, Novel
Actavisf,17
Ranolazine
Lupin, Teva
February 201981
Azithromycin 1% ophthalmic
solution
Fosaprepitant injection
Mylan,f,13 Sandoz
March 2019e,13,43
Accord,h,53 Fresenius Kabi, Sandoz
March 201935
Fulvestrant
Sandozf,144
March 2019144
Deferasirox tablets for oral

suspension
Itraconazole solution
Actavis, Mylanh,11
April 2019d
Ferah,132
June 2019d
September 2018 (or earlier)78

October 2018e,10
January 2019 (or earlier)17
More. . .
Branda
(Manufacturer)
Generic Name
Uloric
(Takeda)
Edluar
(Orexo)
Fentora
(Cephalon)
Treanda
(Teva)
Daliresp
(AstraZeneca)
Namenda XR
(Forest)
Silenor
(Somaxon)
Vigamox
(Alcon)
Delzicol
(Warner Chilcott)
Safyral
(Bayer)
Chantix
(Pfizer)
Dexilant
(Takeda)
Lialda
(Shire)
Absorica
(Ranbaxy)
Ofirmev
(Mallinckrodt)
Febuxostat
Alembic, Dr. Reddys,h,97 Hetero,h,97 Lupin,h,97

Mylan, Ranbaxy,h,97 Roxane,h,106 Sunh,97
Mylan, Par
June 2019d,16
Zolpidem sublingual tablet
September 2019e,154.155
Fentanyl citrate buccal/sublingual

tablet
Bendamustine 25 mg/vial and
100 mg/vial
Roflumilast
Actavis,f,72 Impax,f,57 Mylanf,89
October 201972
Accord, Glenmark, Hospira, InnoPharma,

Sagentf,107
Strides
November 2019111
Memantine extended-release
capsule
Doxepin
Amneal,f,3 Mylan, Sun,h,118 Teva,f,58

Wockhardth,118
Actavis, Mylan, Par, Zydus
Moxifloxacin ophthalmic
Actavis, Akorn, Apotex, Lupin, Teva
March 2020e,6
Mesalamine delayed-release
capsule
Drospirenone/Ethinyl
estradiol/Levomefolate calcium
Varenicline
Mylanh,115
April 2020d
Actavis
April 2020d,46
Apotex, Mylan, Teva
May 2020d,49
Dexlansoprazole
June 2020104
Mesalamine delayed-release tablet
Impax,f,104 Par (acquired Handas ANDA),132

TWif,93
Allergan,f,42,145 Mylan,h,38 Zydus,h,76
Isotretinoin
Actavisf,88
December 2020 (or earlier)88
Acetaminophen injection
Paddock, Perrigo,31 Sandoz
December 2020 (or earlier)31
January 2020156
January 20203
June 202042,145
More. . .
Branda
(Manufacturer)
Generic Name
Latisse
(Allergan)
Sutent
(Pfizer)
Tarceva
(OSI)
Diclegis
(Duchesnay)
Perforomist
(Mylan)
Bystolic
(Forest)
Bimatoprost 0.03%
Apotex, Sandoz
January 202145
Sunitinib
Mylan
February 2021
Erlotinib tablet
Mylan
May 2021e,141
Doxylamine/Pyridoxine
Actavis
June 2021e,158
Formoterol inhalation solution
Teva
June 2021
Nebivolol
September 2021 (or earlier)67
Emtriva
(Gilead)
Brovana
(Sunovion)
Revlimid
(Celgene)
Vimpat
(UCB)
Emtricitabine capsule
Actavis,f,67 Alkem,f,67 Amerigen,f,67

Glenmark,f,63,67 Hetero,f,67 Indchemie,f,67
Torrentf,67
Aurobindo, Cipla, Matrix
September 2021d,4
Arformoterol
Teva
November 2021
Lenalidomide
Allerganf,23
March 202223
Lacosamide
Tablet: Accord, Actavis, Alembic, Amneal,

Aurobindo, Glenmark, MSN, Mylan, Sun
Oral solution: Amneal, Apotex, Glenmark
March 20225
Zipsor
(Depomed)
Alimta
(Lilly)
Banzel
(Eisai)
Diclofenac potassium liquid-filled

capsule
Pemetrexed
Actavis,f,95 Biopharma
March 2022 (or earlier)95
Accord, APP, Emcure,h,69 Heritage,h,69

Hospira, Sandoz,h,56 Teva
Glenmark, Hetero,h,80 Lupin,h,80 Mylan,
Roxane
May 2022d
Viibryd
(Forest)
Vilazodone
Teva
June 2022d,21
Rufinamide
May 2022 (or earlier)48
More. . .
Branda
(Manufacturer)
Generic Name
Januvia
(Merck)
Toviaz
(Pfizer)
Sitagliptin
Actavis, Apotex, Mylan, Sandoz, Sun, Teva
July 2022d,21,124
Fesoterodine extended-release
tablet
July 2022d,82,147
Pralatrexate
Actavis, Accord,h,108 Alembic, Amerigen,

Amneal, Aurobindo, Cadila,h,108 Dr. Reddys,
Impax,h,108 Mylan,h,147 Lupin, Sandoz, Sun,
Wockhardt,h,82 Zydush,108
Teva
November 2022149
Maraviroc
Hetero
November 2022d,21
Sodium oxybate
Amneal,h,7 Par,h,7 Roxaneh,7
December 2022d,7
Prasugrel
Aurobindo, Hec Pharm,h,26 Mylan, Parh,148
January 2023d
Naproxen/Esomeprazole
magnesium delayed-release tablet
Lisdexamfetamine
Actavis,h,77 Anchen,h,77 Dr. Reddys, Lupin,h,77

Mylanh,77
Actavis, Amneal, Mylan, Roxane, Sandoz
February 2023d,77
Magnesium sulfate anhydrous,

potassium sulfate, sodium sulfate
Rilpivirine
Paddock
March 2023
Strides Arcolab
April 2023
Gabapentin
Actavis, Incepta,f,98 Zydusf,98
January 2024 (or earlier)62,98
Pitavastatin
Aurobindo, Mylan,h,138 Zydush,136
February 2024d
Olopatadine 0.2% ophthalmic

solution
Tapentadol tablet
Actavis, Apotex, Teva, Wockhardth,100
May 2024d
Actavis, Alkem, Roxane
June 2025d,125
Dasatinib
Apotex
March 2026e,152
Folotyn
(Spectrum)
Selzentry
(Pfizer)
Xyrem
(Jazz)
Effient
(Eli Lilly)
Vimovo
(Horizon)
Vyvanse
(Shire)
Suprep
(Braintree)
Edurant
(Janssen)
Gralise
(Depomed)
Livalo
(Kowa)
Pataday
(Alcon)
Nucynta
(Depomed)
Sprycel
February 202355
More. . .
Branda
(Manufacturer)
Generic Name
Janumet
(Merck)
Janumet XR
(Merck)
Natazia
(Bayer)
Aplenzin
(Valeant)
Cambia
(Depomed)
Nuedexta
(Avanir)
AndroGel 1.62%
(AbbVie)
Ampyra
(Acorda)
Lumigan
(Allergan)
Epiduo
(Galderma)
Fanapt
(Vanda)
Nexavar
(Bayer)
Oracea
(Galderma)
Promacta
(Novartis)
Sitagliptin/Metformin
Actavis, Apotex, Sandoz
April 2026d,21
Sitagliptin/Metformin extendedrelease tablet

Dienogest/estradiol valerate
Anchen, Teva
April 2026d,21
Actavis, Lupin,h,61 Teva
May 2026d,61
Bupropion hydrobromide
extended-release tablet
Diclofenac potassium oral
solution 50 mg
Dextromethorphan/Quinidine
Actavis, Paddock,h,105 Parf,83
June 2026e,83
Par
June 2026e,150
Impax,f,116 Par, Sandoz,f,103 Wockhardtf,85
July 2026 (or earlier)85,103
Testosterone
Actavis,h,44 Perrigo
October 2026d
Dalfampridine extended-release
tablet
Bimatoprost ophthalmic solution
0.01%
Adapalene 0.1%/Benzoyl
peroxide 2.5%
Iloperidone
Accord, Actavis, Allergan,f,96,119 Aurobindo,

Roxane, Alkem, Mylan,h,96 Sun, Teva
Actavis,f,123 Apotex, Hi-Tech,f,123 Lupin,f,123
Sandoz
Actavis, Glenmark, Parf,131
2027 (or earlier)e,96,119-122
July 2027e,131
Inventia, Roxanef,157
November 2027157
Sorafenib
Mylan
December 2027d,21
Doxycycline 40 mg capsule
Amneal, Lupin, Mylan
December 2027110
Eltrombopag
Hetero
February 2028d,21
Differin
(Galderma)
Adapalene topical solution 0.1%
Call (Rochester)
May 2028
June 2027123
More. . .
Branda
(Manufacturer)
Generic Name
Canasa
(Aptali)
Nucynta ER
(Depomed)
Onglyza
Staxyn
(Bayer)
Pennsaid
(Horizon)
Colcrys
(Takeda)
Lo Loestrin Fe
(Actavis)
Tygacil
(Wyeth)
Isentress
(Merck)
Quartette
(Teva)
Moxeza
(Alcon)
Qsymia
(Vivus)
Savella
(Forest)
Tykerb
(Novartis)
Travatan Z
(Alcon)
Suboxone
(Reckitt Benckiser)
Mesalamine rectal suppository 1 g
Mylan, Sandoz
June 2028d,133
Tapentadol extended-release
tablet
Saxagliptin
Actavis
September 2028d,125
Actavis,h,99 Amneal, Aurobindo, Par
November 2028d
Vardenafil orally disintegrating

tablet
Diclofenac sodium 2% solution
Actavis, Macleods, Par
December 202840
Amneal, Lupin, Paddock, Perrigo,f,66 Taro
Colchicine
Actavis, Hikma,h,64 Par
February 2029d
Ethinyl estradiol/Norethindrone
acetate/Ferrous fumarate
Tigecycline injection
Glenmark, Jai (Mylan)
February 2029e,32
Fresenius Kabi, Sandoz
February 202974
Raltegravir tablet
Hetero
March 2029d,21
Levonorgestrel/Ethinyl estradiol
Lupin
March 2029d,21
Moxifloxacin ophthalmic solution
Lupin
May 2029d,6
Phentermine/Topiramate
extended-release capsule
Milnacipran
Actavish,41
June 2029d
Amneal, Apotex,h,14 Glenmark,f,127 Hetero,h,14

Lupin, Mylan, Par,h,14 Ranbaxyh,14
Natco
September 2029e,127 (may be

authorized generic)
September 2029d,21
Apotex, Mylan, Par
October 2029d,128
Actavish,86
March 2030d
Lapatinib
Travoprost 0.004% ophthalmic
solution
Buprenorphine/Naloxone
sublingual film
More. . .
Branda
(Manufacturer)
Generic Name
Jevtana
(Sanofi Aventis)
Giazo
(Valeant)
Multaq
(Sanofi-Aventis)
Contrave
(Orexigen)
Zubsolv
(Orexo)
Alocril
(Allergan)
Avandamet
(SB Pharmco)
Avandaryl
(SB Pharmco)
Avandia
(SB Pharmco)
Axiron
(Eli Lilly)
Cabazitaxel
Breckenridgeh,54
October 2030d
Balsalazide 1.1 g tablet
Apotex,h,129 Par, Mylan
June 2031e,75
Dronedarone
Actavis, Alkem, Glenmark
June 2031
Bupropion/Naltrexone sustained
release tablet
Buprenorphine/Naloxone
sublingual tablet
Nedocromil ophthalmic
Actavish,114
January 2032d
Actavish,84
September 2032d
Akorn
Uncertaing
Rosiglitazone/Metformin
Teva
Uncertain27 (brand discontinued)
Rosiglitazone/Glimepiride
Teva
Uncertain27 (brand discontinued)
Rosiglitazone
Uncertain27
Testosterone transdermal solution
Actavis, Dr. Reddys, Mylan, Roxane,

Sandoz, Teva, Hikma
Actavis, Amneal,h, 112 Lupin,h,112 Perrigo
Bloxiverz
(Eclat)
CellCept
(Roche Palo)
Exalgo
(Mallinckrodt)
Exelon
(Novartis)
Neostigmine
Eurohealth
Uncertain (patents invalidated;

generic could launch during appeal
process)112
Uncertaing
Mycophenolate mofetil
hydrochloride injection
Hydromorphone extended-release
tablet 32 mg
Rivastigmine oral solution (brand
discontinued)
Bedford Labs
Uncertaing
Actavis, Osmotica
Uncertaing
Ranbaxy
Uncertaing (brand discontinued)
Oxytrol
(Actavis)
Oxybutynin transdermal patch
Teva
Uncertain37
More. . .

Branda
(Manufacturer)
Generic Name
Prandimet
(Novo Nordisk)
Renagel
(Genzyme)
Renvela
(Genzyme)
Rezira
(Hawthorn)
Repaglinide/metformin tablet
Lupin
Uncertaing
Sevelamer hydrochloride (oral

suspension)(brand not available)
Sevelamer carbonate (oral
suspension)
Hydrocodone/pseudoephedrine
oral solution
Impaxf,15
Uncertain (brand discontinued)
Impaxf,15
Uncertaing
Coastal, Tris Pharma, Paddock (Perrigo)
Uncertaing
Sarafem
(Apil)
Welchol
(Daiichi Sankyo)
Fluoxetine tablet
Teva
Uncertaing
Colesevelam tablet and oral

suspension
Impax,f,22 Actavis,h,71 Glenmarkf,59
Uncertain22,59
a.
b.
c.
d.
e.
f.
g.
h.
i.
This list is not all-inclusive.

Current through August 2016. These are manufacturers with either approval or tentative approval to market the generic version of the drug unless
otherwise noted. For drugs already available, manufacturers with tentative approval are not listed.
Generic availability is subject to change as a result of litigations and patent exclusivities.
Patent challenged; availability may be sooner than patent expiration date.
Generic manufacturer has settled patent litigation with the brand manufacturer. Generic availability may be sooner than patent expiration date.
Generic manufacturer has not received approval or tentative approval from the FDA, but has settled patent litigation with the brand manufacturer.
Patents have expired; however, generics are not yet available.
Generic manufacturer has not received approval or tentative approval from the FDA, but has filed patent challenge.
A biosimilar is not a generic. Biosimilars and their reference product are complex biologic medicines that originate in living organisms. A biosimilar is not
the exact duplicate of the reference biologic, but is very similar and is expected to have the same efficacy and safety for its approved indications.60
Users of this resource are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical
judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national
organizations. Information and internet links in this article were current as of the date of publication.
More. . .
Project Leader in preparation of this professional

resource: Melanie Cupp, Pharm.D., BCPS
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litigation.
April
27,
2015.
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94. Koenig B. Dr. Reddys files first paragraph IV ANDA
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95. Depomed settles Zipsor patent litigation with Watson
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666&sid=2. (Accessed August 26, 2016).
96. Zacks Equity Research. Acorda gets favorable court
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(Accessed
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97. Wilson D. Teijin, Takeda accuse Lupin of infringing
Uloric
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(Accessed
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98. Anon. Depomed announces settlements with two
Gralise
ANDA
filers.
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99. Anon. Actavis confirms generic Onglyza patent
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100. Anon. Alcon sues Wockhardt for patent infringement
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101. Anon. Genzyme hits Sun with suit over generic
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b/newsheadlines/archive/2016/03/24/genzyme-hitssun-with-suit-over-generic-leukemiadrug.aspx?Redirected=true. (Accessed August 22,
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102. Anon. Pozen patents upheld in Treximet patent
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103. Anon. Avanir, Sandoz settle Nuedexta patent suit.
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avanir-sandoz-settle-nuedexta-patent-suit46708.html. (Accessed August 27, 2016).

104. Lawson A. Takeda triumphs in suits to block generic
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November
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nd
105. Grande A. Biovail hits Paddock with 2 suit over
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106. Anon. Roxane faces patent infringement suit over
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107. Anon. Teva announces favorable court ruling in
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108. Dugdale M. Pfizer seeks Toviaz protection. July 2,
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ws/article.php?article_id=17#.Vnn1CTZIhNQ.
109. Melander I, Koppala AR. Sanofi, Eli Lilly reach deal
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110. Williams A. Research Foundation of State University
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111. Anon. Glenmark Pharma gets US FDA approval for
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28,
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112. Anon. Acrux and Eli Lilly to appeal patent ruling on
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August
24,
2016.
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8052BA82CDD4823A4D4C0625. (Accessed August
27, 2016).
letter. Sandoz generic Emend. May 13, 2016.
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a/2012/090999Orig1s000Approv.pdf.
(Accessed
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114. Anon. Orexigen announces receipt of paragraph IV
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April
22,
2015.
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2016).
More. . .
115. Anon. Mylan in patent lawsuit. November 20, 2015.

https://pharmaceuticaldaily.com/2015/11/20/mylanin-patent-lawsuit/. (Accessed August 24, 2016).
116. Lawson A. Avanir prevails over Par, Impax in
Nuedexta
patent
row.
May
1,
2014.
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117. United States District Court for the District of New
Jersey. Medicis Pharmaceuticals Corporation vs
Apotex Inc. and Apotex Corp. Complaint for patent
infringement.
April
15,
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118. Anon. Forest Laboratories, Inc. (FRX) files lawsuit
against several companies for infringement of
Namenda XR patents.
February 3, 2014.
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29, 2016).
119. Anon. Acorda soars, settles patent dispute with
Allergan.
October
6,
2015.
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120. Anon.
Acorda Therapeutics (ACOR) discloses
settlement agreement with Actavis regarding
Ampyra.
October
5,
2015.
https://www.briefing.com/investor/analysis/storystocks/acorda-therapeutics-(acor)-disclosessettlement-agreement-with-actavis-regardingampyra.htm. (Accessed August 27, 2016).
121. Anon.
Acorda Therapeutics (ACOR) enters
settlement with Aurobindo Pharma. December 10,
2015.
http://www.streetinsider.com/Corporate+News/Acord
a+Therapeutics+(ACOR)+Enters+Settlement+with+A
urobindo+Pharma/11142542.html.
(Accessed
August 27, 2016).
122. Anon. Sun Pharma settles patent litigation with
Acorda Therapeutics.
October 21, 2015.
http://economictimes.indiatimes.com/industry/healthc
are/biotech/pharmaceuticals/sun-pharma-settlespatent-litigation-with-acordatherapeutics/articleshow/49485454.cms. (Accessed
August 27, 2016).
123. Decker S. Allergan wins lawsuit against Lupin, two
others over Lumigan.
January 15, 2014.
http://www.livemint.com/Companies/jCLthTyvUREQJ
kbyC4in7J/Allergan-wins-lawsuit-against-ActavisNovartis-over-Lumigan.html. (Accessed August 27,
2016).
124. Anon. Sun Pharma gets FDA nod for generic
version
of
Januvia.
April
16,
2013.
http://articles.economictimes.indiatimes.com/201304-16/news/38586739_1_sun-pharma-sitagliptin-usdrug-regulator. (Accessed August 26, 2016).
125. Anon. Depomed announces favorable Markman
ruling in Nucynta and Nucynta ER patent litigation.
February
8,
2016.
https://www.thestreet.com/story/13450532/1/depome
d-announces-favorable-markman-ruling-in-nucynta-
and-nucynta-er-patent-litigation.html.
(Accessed
August 27, 2016).
126. Kass D. Sandoz, UTC settle generic Remodulin
patent
suit.
September
30,
2015.
http://www.law360.com/articles/709188/sandoz-utcsettle-generic-remodulin-patent-suit.
(Accessed
August 31, 2016).
127. Shine J. Glenmark settles patent war over Savella.
December 21, 2015.
http://www.livemint.com/
Companies/OYBtDHxTAbNVlp3RYOkCCI/Glenmarksettles-patent-war-over-Savella.html.
(Accessed
August 27, 2016).
letter. Apotex generic Travatan Z. July 10, 2016.
(Accessed
August 29, 2016).
129. Kass D. Valeant hits Apotex with patent suit over
colitis drug.
October 1, 2015.
http://www.law
360.com/articles/709788/valeant-hits-apotex-withpatent-suit-over-colitis-drug. (Accessed August 29,
2016).
130. James B. ViiV, Vertex sue over Mylans bid to
market generic Lexiva.
August 24, 2012.
http://www.law360.com/articles/372465/viiv-vertexsue-over-mylan-s-bid-to-market-generic-lexiva.
131. Davis R. Galderma, Actavis settle generic Epiduo
suit ahead of trial. April 13, 2015. http://www.law
360.com/articles/642310/galderma-actavis-settlegeneric-epiduo-suit-ahead-of-trial.
(Accessed
August 27, 2016).
132. Anon. Par Pharmaceutical acquires rights to market
and distribute generic Dexilant in the U.S. April 19,
2012.
https://www.thestreet.com/story/11501680/2/parpharmaceutical-acquires-rights-to-market-anddistribute-generic-dexilant-in-the-us.html. (Accessed
August 24, 2016).
133. Anon. Mylan confirms first-to-file patent challenge
relating
to
Canasa.
July
11,
2013.
http://www.prnewswire.com/news-releases/mylanconfirms-first-to-file-patent-challenge-relating-tocanasa-215055171.html.
2016).
134. Voreacos D, Decker S. Teva wont sell generic
Vytorin until 2017 under accord. July 8, 2011.
http://www.bloomberg.com/news/articles/2011-0708/teva-won-t-sell-generic-vytorin-until-2017-settlingmerck-patent-lawsuit. (Accessed August 22, 2016).
135. Anon.
Sunovion Pharmaceuticals files patent
infringement lawsuits regarding Latuda. January 14,
2015.
http://www.pharmpro.com/news/2015/01/sunovionpharmaceuticals-files-patent-infringement-lawsuitsregarding-latuda%C2%AE. (Accessed August 22,
2016).
136. Anon. Aurobindo Pharma lands in patient litigation
cases
in
USA.
April
28,
2014.
http://articles.economictimes.indiatimes.com/201404-28/news/49464640_1_aurobindo-pharma-patentinfringement-hospira. (Accessed August 26, 2016).
More. . .
137. Keshavan M. Which drugs are going off-patent in

2016? January 4, 2016. http://medcitynews.com
/2016/01/drugs-off-patent/?rf=1. (Accessed August
29, 2016).
138. Westney A. Mylan hit with IP suit over generic
cholesterol
drug.
April
18,
2014.
http://www.law360.com/articles/529679/mylan-hitwith-ip-suit-over-generic-cholesterol-drug.
139. Anon. Natco settles suit over Tamiflu. December
15,
2015.
http://www.financialexpress.com/industry/companies/
natco-settles-suit-over-tamiflu/178756/.
(Accessed
September 9, 2016).
140. Anon. Merck wins U.S. Zetia (ezetimibe)/Vytorin
(ezetimibe/simvastatin) patent infringement lawsuit.
April 27, 2012.
http://www.mercknewsroom.com
/press-release/corporate-news/merck-wins-us-zetiaezetimibe-vytorin-ezetimibesimvastatin-patent-infri.
141. Gough PJ. Mylan settles patent lawsuit on generic
Tarceva.
July
25,
2013.
http://www.bizjournals.com/pittsburgh/blog/morningedition/2013/07/mylan-settles-patent-lawsuit-on.html.
142. Broady G. Genzyme sues to stop generic leukemia
treatment.
July
30,
2012.
http://www.law360.com/articles/365169/genzymesues-to-stop-generic-leukemia-treatment. (Accessed
August 22, 2016).
143. Johnson M. Remicade biosimilar to hit US market by
2016
Q4.
August
24,
2016.
http://genericpharmalitigator.com/news/remicadebiosimilar-to-hit-us-market-by-2016-q4.
(Accessed
August 24, 2016).
144. Palmer E. AstraZeneca settles Sandoz patent fight
over its top-selling cancer med. July 13, 2016.
http://www.fiercepharma.com/pharma/astrazenecasettles-sandoz-patent-fight-over-its-top-sellingcancer-med. (Accessed July 22, 2016).
145. Anon.
Shire wins patent trial against Watson
concerning
Lialda.
March
29,
2016.
https://www.shire.com/newsroom/2016/march/shirewins-patent-trial-against-watson-concerning-lialda.
146. Staton T. August 25, 2016. With patent strikedown,
Tevas new Copaxone formula loses two defenses
against
generics.
August
25,
2016.
http://www.fiercepharma.com/pharma/patentstrikedown-teva-s-new-copaxone-formula-loses-twodefenses-against-generics. (Accessed August 26,
2016).
147. Oslick S. Patent docs. Court report. February 1,
2015. http://www.patentdocs.org/2015/02/court.html.
148. Lerner K. Eli Lilly sues Par Pharma to block generic
Effient.
January
29,
2014.
http://www.law360.com/articles/505154/eli-lilly-suespar-pharma-to-block-generic-effient.
(Accessed
August 26, 2016).
149. Anon. Spectrum Pharmaceuticals settles Folotyn
(pralatrexate injection) ANDA patent litigation. July
13, 2016. http://finance.yahoo.com/news/spectrumpharmaceuticals-settles-folotyn-pralatrexate110000957.html. (Accessed August 26, 2016).
letter.
Mylan generic Cambia.
May 2, 2016.
(Accessed
August 31, 2016).
151. OptumRx.
Minastrin 24 Fe (norethindrone
acetate/ethinyl estradiol/ferrous fumarate)-first-time
generic.
https://hcpprod.optumrx.com/vgnlive/HCP/Assets/RxNews/New
%20Generics_Minastrin%2024%20Fe_20160527.pdf. (Accessed August 31, 2016).
letter.
Apotex generic Sprycel.
June 10,
2016http://www.accessdata.fda.gov/drugsatfda_docs
/appletter/2016/202103Orig1s000ltr.pdf. (Accessed
August 31, 2016).
153. Edenbridge Pharmaceuticals. News. June 30, 2016.
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Interim report January-June 2015.
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/30/wkr0006.pdf. (Accessed August 31, 2016).
156. Anon. Strides Shasun receives USFDA tentative
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157. Anon. Vanda patents found valid and infringed in
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letter. Actavis generic Diclegis. August 19, 2016.
(Accessed
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159. Johnson LA, Perrone M. Novartis wins US OK for
biosimilar of Amgens Enbrel.
http://www.timesstandard.com/article/zz/20160830/NEWS/160839822.
More. . .
Cite this document as follows: Professional Resource, Anticipated Availability of First-Time Generics. Pharmacists
Letter/Prescribers Letter. September 2016.
Evidence and Recommendations You Can Trust

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Subscribers to the Letter can get professional resources, like this one,
on any topic covered in any issue by going to PharmacistsLetter.com,
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Detail-Document #250801
This Detail-Document accompanies the related article published in

August 2009 ~ Volume 25 ~ Number 250801
Angiotensin Receptor Blocker (ARB) Antihypertensive Dose Comparison

(Full update February 2012)
NOTE: When switching products consider indication, liver function, renal function, other medical conditions, and allergies. Dose equivalencies are
approximate; individual responses may vary. Monitor blood pressure, potassium, and renal function.
Abbreviations: BID=twice daily; MI=myocardial infarction; QD=once daily
Drug
Comparable dose based on therapeutic interchange studies, comparative
clinical trials, and manufacturers recommended dosing for hypertension.1-19,21,22,23
*Shaded area denotes manufacturers recommended starting dose for hypertension*
(See footnotes regarding lower doses)
Azilsartan (Edarbi)
40 mg QDc
40 mg QDc
40 mg QDc
40 mg QDc
Candesartan (Atacand)
4 mg QDa
8 mg QD or
divided BID
16 mg QD or
divided BIDb
16 mg QD or
divided BIDb to
32 mg QD or
divided BID
---
Eprosartan (Teveten)
400 mg QD
600 mg QDL
75 mg QDc
150 mg QD
800 mg QD or
divided BIDd
300 mg QD
---
Irbesartan (Avapro)
800 mg QD or
divided BIDd
300 mg QD
Losartan (Cozaar)
25 mg QDe
Olmesartan (Benicar)
10 mg QD
50 mg QD or
divided BIDn
20 mg QDf
Telmisartan (Micardis)
20 mg QD
40 mg QDg
Valsartan (Diovan)
40 mg QD or
20 mg BIDh
80 mg QDj or
40 mg BIDi,m
100 mg QD or
divided BIDn
20 mg QDf to
40 mg QD
40 mg QDg to
80 mg QD
160 mg QDj
80 mg QD
---
---
---
40 mg QD
---
80 mg QD
---
320 mg QDk,m
--More. . .

Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #250801: Page 2 of 3)
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
L.
m.
n.
Starting dose for heart failure.3

Consider lower starting dose for moderate hepatic impairment or volume-depleted patients.3
Starting dose for volume/sodium-depleted patients.6,17
Maximum dose is 600 mg QD in moderate or severe renal impairment.5
Starting dose for volume/sodium-depleted patients or patients with (or with a history of) hepatic impairment.7
Consider lower starting dose for volume-depleted patients.8
Use lower starting dose for hepatic impairment or volume/sodium-depleted patients.9
Starting dose post-MI.10
Starting dose for heart failure.10
Recommended initial dose for hypertension monotherapy in patients who are not volume-depleted. Dose cautiously in hepatic or severe renal
impairment.10
Divide BID for post-MI and heart failure indications.10
Recommended initial dose for monotherapy in patients who are not volume-depleted.5
Dose cautiously in hepatic or severe renal impairment.10
Losartan may not control blood pressure as well as other ARBs.20 BID dosing may improve blood pressure control.7
Users of this document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical
organizations. Information and Internet links in this article were current as of the date of publication.
More. . .
Project Leader in preparation of this DetailDocument: Melanie Cupp, Pharm.D., BCPS
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Zannad F, Fay R. Blood pressure-lowering efficacy

of olmesartan relative to other angiotensin II receptor
antagonists: an overview of randomized controlled
studies. Fundam Clin Pharmacol 2007;21:181-90.
Sease J, Williams AM.
Equivalent doses in
irbesartan, valsartan, and losartan identified through
formulary switch at a Veterans Affairs medical
center. Formulary 2008;43:14-20.
Product information for Atacand. AstraZeneca LP.
Wilmington, DE 19850. April 2011.
Puig JG, Lopez MA, Bueso TS, et al. Clinical profile
of eprosartan. Cardiovasc Drugs Ther 2002;16:5439.
Product information for Teveten.
Abbott
Laboratories. North Chicago, IL 60064. December
2011.
Product information for Avapro.
Bristol-Myers
Squibb Company. Princeton, NJ 08543. January
2012.
Product information for Cozaar. Merck & Co., Inc.
Whitehouse Station, NJ 08889. November 2011.
Product information for Benicar. Daiichi Sankyo, Inc.
Parsippany, NJ 07054. June 2011.
Product information for Micardis.
Boehringer
Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT
06877. January 2012.
Product information for Diovan.
Novartis
Pharmaceuticals Corporation. East Hanover, NJ
07936. January 2012.
Asmar R. Targeting effective blood pressure control
with angiotensin receptor blockers. Int J Clin Pract
2006;60:315-320.
Elliott WJ, Calhoun DA, DeLucca PT, et al. Losartan
versus valsartan in the treatment of patients with mild
to moderate essential hypertension: data from a
multicenter, randomized, double-blind, 12-week trial.
Clin Ther 2001;23:1166-79.
Nakayama S, Watada Hm Mita T, et al. Comparison
of effects of olmesartan and telmisartan on blood
pressure and metabolic parameters in Japanese
early-stage type-2 diabetes with hypertension.
Hypertens Res 2008;31:7-13.
14. Sasaki T, Noda Y, Yasuoka Y, et al. Comparison of

the effects of telmisartan and olmesartan on home
blood pressure, glucose, and lipid profiles in patients
with hypertension, chronic heart failure, and
metabolic syndrome. Hypertens Res 2008;31;921-9.
15. Whittaker A. A review of olmesartan medoxomila
new angiotensin II blocker.
Br J Cardiol
2005;12;125-9.
16. Brunner HR, Stumpe KO, Januszewicz A.
Antihypertensive efficacy of olmesartan medoxomil
and candesartan cilexetil assessed by 24-hour
ambulatory blood pressure monitoring in patients
with essential hypertension.
Clin Drug Investig
2003;23:419-30.
17. Product
information for
Edarbi.
Takeda
Pharmaceuticals America, Inc. Deerfield, IL 60015.
December 2011.
18. Bakris GL, Sica D, Weber M, et al. The comparative
effects of azilsartan medoxomil and olmesartan on
ambulatory and clinic blood pressure.
J Clin
Hypertens 2011;13:81-8.
19. White WB, Weber MA, Sica D, et al. Effects of the
angiotensin receptor blocker azilsartan medoxomil
versus olmesartan and valsartan on ambulatory and
clinic blood pressure in patients with stages 1 and 2
hypertension. Hypertension 2011;57:413-20.
20. VA/DoD drug class review. Angiotensin II receptor
antagonists (AIIRAs).
Update February 2010.
http://www.pbm.va.gov/Clinical%20Guidance/Drug%
20Class%20Reviews/Angiotensin%20II%20Receptor
%20Antagonists,%20Drug%20Class%20Review.pdf.
(Accessed February 13, 2012).
21. Smith DH. Comparison of angiotensin II type 1
receptor antagonists in the treatment of essential
hypertension. Drugs 2008;68:1207-25.
22. Giles TD, Oparil S, Silfani TN, et al. Comparison of
increasing doses of olmesartan medoxomil, losartan
potassium, and valsartan in patients with essential
hypertension. J Clin Hypertension 2007;9:187-95.
23. Smith DH, Dubiel R, Jones M. Use of 24-hour,
ambulatory blood pressure monitoring to assess
antihypertensive efficacy:
a comparison of
olmesartan
medoxomil,
losartan
potassium,
valsartan, and irbesartan. Am J Cardiovasc Drugs
2005;5:41-50.
Cite this Detail-Document as follows: Angiotensin receptor blocker (ARB) antihypertensive dose comparison.
Pharmacists Letter/Prescribers Letter 2009 (Full update February 2012);25(8):250801.
Evidence and Advice You Can Trust

3120 West March Lane, P.O. Box 8190, Stockton, CA 95208 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249
Subscribers to Pharmacists Letter and Prescribers Letter can get Detail-Documents, like this one, on any
topic covered in any issue by going to www.pharmacistsletter.com or www.prescribersletter.com
Detail-Document #260301
This Detail-Document accompanies the related article published in

March 2010 ~ Volume 26 ~ Number 260301
Comparison of Angiotensin Receptor Blockers

(Full update February 2012)
Abbreviations: ACEI = angiotensin-converting enzyme inhibitor; CHF = congestive heart failure; CrCl = creatinine clearance; CV = cardiovascular;
DM = diabetes mellitus; HCT = hydrochlorothiazide; HTN = hypertension; LVH = left ventricular hypertrophy; MI = myocardial infarction
Medication
Initial Dosea
Maintenance Dosea
FDAClinical Benefit
How Supplied/CostL
a,h
Approved
in
a
Indication
Azilsartan
HTN: 80 mg once daily23,f
80 mg once daily23,f
Hypertension
40, 80 mg
(Edarbi)
$82.66 (80 mg once daily)
With chlorthalidone
(Edarbyclor; not for
volume-depleted patients):
40/12.5, 40/2527
Candesartan
(Atacand)
HTN: 16 mg once daily1,b
HTN:
8-32 mg daily in one
or two divided doses1
Hypertension1
Heart Failure1
CHF: Reduces risk

of CV death or CHF
hospitalization1
CHF: 4 mg once daily1,b

CHF: 32 mg once
daily1
Diabetic retinopathy:
reduces incidence
(type 1 DM) and
improves mild to
moderate retinopathy
(type 2 DM)2,3
Nephropathy (type 2
DM): reduces
microalbuminuria14
4, 8, 16, 32 mg1
$104.99 (32 mg once
daily)
With HCT (Atacand HCT;
indicated for HTN only;
not for initial therapy; not
recommended if CrCl
<30 mL/min): 16/12.5,
32/12.5,
32/25 mg4
More. . .
Medication
Initial Dosea
Maintenance Dosea
Eprosartan
(Teveten)
600 mg once daily5,c
400-800 mg daily in
one or two divided
doses5
Irbesartan
(Avapro)
HTN: 150 mg once daily7,d
HTN: 150-300 mg
once daily7
Nephropathy (type 2
DM): 300 mg once
daily7
Losartan
(Cozaar, generics)
HTN: 50 mg once daily9,e
HTN with LVH: 50 mg once

daily9,e
Nephropathy (type 2 DM):
50 mg once daily9,e
Continued
CHF:
12.5 mg once daily (not
currently taking an ARB) or
25 mg once daily (switching
FDAApproved
Indicationa
Hypertension5
How Supplied/CostL
Clinical Benefit
ina,h
400, 600 mg5

$98.66 (600 mg once
daily)
Hypertension7
Nephropathy
(type 2 DM)7
Nephropathy (type 2
DM): reduces rate of
progression7
With HCT (Teveten HCT;

not for initial therapy):
600/12.5, 600/25 mg6
75, 150, 300 mg7
$108 (300 mg once daily)
With HCT (Avalide;
not for volume-depleted
patients; not recommended
if CrCl <30 mL/min):
150/12.5,
300/12.58
HTN:
25-100 mg daily in
one or two divided
doses9
Hypertension9
HTN/LVH:
50-100 mg once daily
(plus HCT if
needed)9
Hypertension
with LVH9
Nephropathy (type 2
DM): 100 mg once
daily9
Nephropathy
(type 2 DM)9
CHF: Reduces risk

of CV death or CHF
hospitalization;10
mortality similar to
captopril34
HTN with LVH:

reduces stroke risk
(may not benefit
African-Americans)9
25, 50, 100 mg9

$79.55 (100 mg once
daily)
With HCT (Hyzaar;
indicated for HTN and
HTN with LVH only; not
for volume-depleted
if CrCl <30 mL/min):
50/12.5, 100/12.5,
100/25 mg11
More. . .
Medication
Initial Dosea
Maintenance Dosea
Losartan, cont.
from another ARB)10

(Off-label use)
CHF: 150 mg once

daily10 (Off-label)
Olmesartan
(Benicar)
20 mg once daily12,g
20-40 mg once
daily12
FDAApproved
Indicationa
Hypertension12
How Supplied/CostL
Clinical Benefit
ina,h
Nephropathy (type 2
DM): reduces rate of
progression9
Type 2 DM: delays
onset of
microalbuminuria,
but with increased
risk of fatal CV
events among
patients with
coronary artery
disease28
5, 20, 40 mg12
$129.32 (40 mg once
daily)
With HCT (Benicar HCT;
recommended if CrCl <30
mL/min): 20/12.5,
40/12.5,
40/25 mg13
With amlodipine (Azor):
5/20, 10/20, 5/40,
10/40 mg21
With HCT and amlodipine
(Tribenzor; not for initial
therapy; not for volumedepleted patients; avoid if
CrCl <30 mL/min):
20/5/12.5, 40/5/12.5,
40/5/25, 40/10/12.5,
40/10/25 mg22
Telmisartan
(Micardis)
Continued
HTN: 40 mg once daily15,i

CV risk reduction (in patients
unable to take ACE
HTN: 40-80 mg once Hypertension15

daily15
CV risk
reduction in
High CV risk:
reduces risk of CV
events15
20, 40, 80 mg15

$108.65 (80 mg once
daily)
More. . .

Medication
Initial Dosea
Maintenance Dosea
Telmisartan, cont.
inhibitors):
80 mg once daily15,i
CV risk reduction:
80 mg once daily15
FDAApproved
Indicationa
patients unable
to take ACEI15
Clinical Benefit
ina,h
How Supplied/CostL
Nephropathy (type 2
DM): reduces
microalbuminuria,16
slows progression as
well as enalapril,32
and reduces
proteinuria in patients
with HTN29,30
With HCT (Micardis HCT;

for volume-depleted
patients; not
recommended if CrCl
<30 mL/min): 40/12.5,
80/12.5, 80/25 mg17
Hemodialysis
patients with CHF:
added to ACEI,
reduces all-cause and
CV mortality, and
heart failure
hospitalization24
Valsartan
(Diovan)
40, 80, 160, 320 mg18
HTN: 80-160 mg once

daily18,j,k
HTN: 80-320 mg
once daily18
Hypertension
CHF: reduces
hospitalization18
CHF: 40 mg twice daily18,k
CHF: 40-160 mg
twice daily (target
160 mg twice daily)18
Heart Failure
(Class II to IV)
Post-MI: 20 mg twice daily18,k
Post-MI: 20-160 mg
twice daily (target
160 mg twice daily)18
Post-MI with
left ventricular
dysfunction/
failure
Post-MI with left

ventricular
dysfunction/failure:
reduces CV
mortality18
$128 (320 mg once daily)
Continued
Nephropathy (type 2
DM): reduces
microalbuminuria,19
and proteinuria in
patients with HTN30
With HCT (Diovan HCT;

if CrCl <30 mL/min.):
80/12.5, 160/12.5, 160/25,
320/12.5, 320/25 mg20
With amlodipine (Exforge;
indicated for HTN only):
5/160, 10/160, 5/320,
More. . .
Medication
Valsartan, cont.
Initial Dosea
Maintenance Dosea
FDAApproved
Indicationa
Clinical Benefit
ina,h
How Supplied/CostL
HTN with high CV

risk: reduces CV
morbidity/mortality
about as well as
amlodipine33
10/320 mg25
With amlodipine and HCT
(Exforge HCT; indicated
for HTN only; not for
initial therapy; not for
volume-depleted patients;
avoid if CrCl
<30 mL/min): 5/160/12.5,
10/160/12.5, 5/160/25,
10/160/25, 10/320/25 mg26
With aliskiren (Valturna;
patients): 150/160,
300/320 mg31
a. Indications, dosing, and clinical benefit for adult patients.

b. Consider lower starting dose for moderate hepatic impairment or volume-depleted patients.1
c. Recommended initial dose for monotherapy in patients who are not volume-depleted. Do not exceed 600 mg daily in moderate or severe renal
impairment.5
d. Initial dose of 75 mg once daily recommended for volume/sodium-depleted patients.7
e. Starting dose for volume/sodium-depleted patients or patients with (or with a history of) hepatic impairment is 25 mg once daily.9
f. Starting dose for volume/sodium-depleted patients is 40 mg once daily.23
g. Consider lower starting dose for volume-depleted patients.12
h. Evidence level A; high-quality randomized controlled trials.
i. Use lower starting dose for hepatic impairment or volume/sodium-depleted patients.15
j. Recommended initial dose for monotherapy in patients who are not volume-depleted.18
k. Dose cautiously in hepatic or severe renal impairment.18
L. Cost is for 30-day supply of brand (or generic, if available), per www.drugstore.com at time of writing.
Users of this document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical
organizations. Information and Internet links in this article were current as of the date of publication.
More. . .
Levels of Evidence
In accordance with the trend towards Evidence-Based
Medicine, we are citing the LEVEL OF EVIDENCE
for the statements we publish.
Level
A
C
D
Definition
High-quality randomized controlled trial (RCT)
High-quality meta-analysis (quantitative
systematic review)
Nonrandomized clinical trial
Nonquantitative systematic review
Lower quality RCT
Clinical cohort study
Case-control study
Historical control
Epidemiologic study
Consensus
Expert opinion
Anecdotal evidence
In vitro or animal study
Adapted from Siwek J, et al. How to write an evidence-based clinical

review article. Am Fam Physician 2002;65:251-8.
Project Leader in preparation of this DetailDocument: Melanie Cupp, Pharm.D., BCPS
References
1.
Product information for Atacand. AstraZeneca LP.

Wilmington, DE 19850. April 2011.
2. Sjlie AK, Klein R, Porta M, et al.
Effect of
candesartan on progression and regression of
retinopathy in type 2 diabetes (DIRECT-Protect 2): a
randomised placebo-controlled trial.
Lancet
2008;372:1385-93.
3. Chaturvedi N, Porta M, Klein R, et al. Effect of
candesartan on prevention (DIRECT-Prevent 1) and
progression (DIRECT-Protect 1) of retinopathy in
type 1 diabetes: randomised, placebo-controlled
trials. Lancet 2008;372:1394-402.
4. Product information for Atacand HCT. AstraZeneca
LP. Wilmington, DE 19850. April 2011.
5. Product information for Teveten.
Abbott
Laboratories. North Chicago, IL 60064. January
2012.
6. Product information for Teveten HCT.
Abbott
Laboratories. North Chicago, IL 60064. January
2012.
7. Product information for Avapro.
Bristol-Myers
Squibb Sanofi Synthelabo Partnership. New York,
NY 10016. January 2012.
8. Product information for Avalide.
Bristol-Myers
Squibb Sanofi Synthelabo Partnership. New York,
NY 10016. January 2012.
9. Product information for Cozaar. Merck & Co., Inc.
10. Konstam MA, Neaton JD, Dickstein K, et al. Effects
of high-dose versus low-dose losartan on clinical
outcomes in patients with heart failure (HEAAL
study): a randomised, double-blind trial. Lancet
2009;374:1840-8.
11. Product information for Hyzaar. Merck & Co., Inc.

12. Product information for Benicar. Daiichi Sankyo, Inc.
Parsippany, NJ 07054. June 2011.
13. Product information for Benicar HCT.
Daiichi
Sankyo, Inc. Parsippany, NJ 07054. May 2011.
14. Mogensen CE, Neldam S, Tikkanen I, et al.
Randomised controlled trial of dual blockade of
renin-angiotensin
system
in
patients
with
hypertension, microalbuminuria, and non-insulin
dependent diabetes: the candesartan and lisinopril
microalbuminuria
(CALM)
study.
BMJ
2000;321:1440-4.
15. Product information for Micardis.
Boehringer
Ridgefield, CT
06877. January 2012.
16. Makino H, Haneda M, Babazono T, et al. Prevention
of transition from incipient to overt nephropathy with
telmisartan in patients with type 2 diabetes.
Diabetes Care 2007;30:1577-8.
17. Product information for Micardis HCT. Boehringer
Ridgefield, CT
06877. January 2012.
18. Product information for Diovan.
Novartis
Pharmaceuticals Corp. East Hanover, NJ 07936.
January 2012.
19. Viberti G, Wheeldon NM, MicroAlbuminuria
Reduction with VALsartan (MARVAL) study
investigators.
Microalbuminuria reduction with
valsartan in patients with type 2 diabetes mellitus: a
blood pressure-independent effect.
Circulation
2002;106:672-8.
20. Product information for Diovan HCT.
Novartis
January 2012.
21. Product information for Azor. Daiichi Sankyo, Inc.
Parsippany, NJ 07054. November 2011.
22. Product information for Tribenzor. Daiichi Sankyo,
Inc. Parsippany, NJ 07054. November 2011.
23. Product
information
for
Edarbi.
Takeda
December 2011.
24. Cice G, Di Benedetto A, Dlsa S, et al. Effects of
telmisartan added to angiotensin-converting enzyme
inhibitors on mortality and morbidity in hemodialysis
patients with chronic heart failure a double-blind,
placebo-controlled trial.
J Am Coll Cardiol
2010;56:1701-8.
25. Product information for Exforge.
Novartis
January 2012.
26. Product information for Exforge HCT.
Novartis
January 2012.
27. Product information for Edarbyclor.
Takeda
December 2011.
28. Haller H, Ito S, Izzo JL Jr, et al. Olmesartan for the
delay or prevention of microalbuminuria in type 2
diabetes. N Engl J Med 2011;364:907-17.
More. . .
29. Bakris G, Burgess E, Weir M, et al. Telmisartan is

more effective than losartan in reducing proteinuria in
patients with diabetic nephropathy.
Kidney Int
2008;74:364-9.
30. Galle J, Schwedhelm E, Pinnetti S, et al.
Antiproteinuric effects of angiotensin receptor
blockers:
telmisartan versus valsartan in
hypertensive patients with type 2 diabetes mellitus
and overt nephropathy. Nephrol Dial Transplant
2008;23:3174-83.
31. Product information for Valturna.
Novartis
October 2011.
32. Barnett AH, Bain SC, Bouter P, et al. Angiotensinreceptor
blockade
versus converting-enzyme
inhibition in type 2 diabetes and nephropathy. N
Engl J Med 2004;351:1952-61.
33. Julius S, Kjeldsen SE, Weber M, et al. Outcomes in

hypertensive patients at high cardiovascular risk
treated with regimens based on valsartan or
amlodipine: the VALUE randomised trial. Lancet
2004;363:2022-31.
34. Pitt B, Poole-Wilson PA, Segal R, et al. Effect of
losartan compared with captopril on mortality in
patients with symptomatic heart failure: randomized
trialthe Losartan Heart Failure Survival Study
ELITE II. Lancet 2000;355:1582-7.
Cite this Detail-Document as follows:

Comparison of angiotensin receptor blockers.
Letter/Prescribers Letter 2010 (Full update February 2012);26(3):260301.
Pharmacists
Evidence and Advice You Can Trust

3120 West March Lane, P.O. Box 8190, Stockton, CA 95208 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249
Subscribers to Pharmacists Letter and Prescribers Letter can get Detail-Documents, like this one, on any
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