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Access to Effective
affordable competition
quality
(PRIMARY)
drugs and
medicines Price regulation
for all
Intellectual
Property Office
(IPO)
Administration
(FDA)
Pharmaceutical alternative
refers to products that contain the same
molar amount of the same active
pharmaceutical moiety(s) but differ in dosage
form, and/or chemical form
deliver the same active moiety by the same
route of administration but are otherwise not
pharmaceutically equivalent.
may or may not be bioequivalent or
therapeutically equivalent to the comparator
product
Pharmaceutical equivalence
refers to drug products that contain the
same molar amount of the same active
pharmaceutical ingredient(s) in the same dosage
form, if they meet comparable standards, and if they
are intended to be administered by the same route.
does not necessarily imply therapeutic
equivalence, as differences in the excipients and/or
the manufacturing process and some other
variables can lead to differences in product
performance.
Therapeutically equivalent
refers to two pharmaceutical products that
are pharmaceutically equivalent or
pharmaceutical alternatives and after
administration in the same molar dose, their
effects, with respect to both efficacy and
safety, are essentially the same when
administered to patients by the same route.
Interchangeable pharmaceutical
product
drug which is therapeutically equivalent
to an innovator drug and can be
interchanged with the innovator drug in clinical
practice.
It does not necessarily refer to
Bioavailability/Bioequivalence (BA/BE),
which is not applicable to all drug products.
Non-traditional outlets
refers to supermarkets, convenience
stores, other retail establishments duly
licensed by the BFAD to sell over-the-counter
drugs
AmendED:
RA 8293 - Intellectual Property
Code of the Philippines
Access to Effective
affordable competition
quality
(PRIMARY)
drugs and
medicines Price regulation
for all
COMPULSORY
LICENSE
USE BY
GOVERNMENT
EFFETIVE
COMPETITION
SPECIAL
COMPULSORY
LICENSE
PARALLEL
IMPORTATION
1. Introduction in
the Philippines or
Anywhere Else in
the World
2. Private and
Non-commercial
scale or purpose
3. Experimental Use
for Scientific or
Educational
Purposes
4. Regulatory Evaluation
and Approval
a) Use of Data by BFAD
b) Data Protection from
Unfair Commercial
Use
5. Preparation in a
Pharmacy or by a
Medical Professional
6. Ship, Vessel,
Aircraft or Land
Vehicle Use
FIRST
PATENT
PATENT
SECOND
PATENT
Imports of a patented or
trademarked product from a country
where it is already marketed. (WHO)
Civil Action
Patent Infringement
The making, using, offering for sale,
selling, or importing a patented product or a
product obtained directly or indirectly from
a patented process, or the use of a patented
process without the authorization of the
patentee
Access to Effective
affordable competition
quality
(PRIMARY)
drugs and
medicines Price regulation
for all
e-EDPMS
COSTCONTAINMENT
MEASURES
PRICE
REGULATION
AGAINST
ILLEGAL PRICE
MANIPULATION
MDRP
FDA Implementation
FDA Circular No. 2010-017 - dated 04 October 2010
Department Circular No. 2010-0200 - dated 16 July 2010
Include in the inspection parameters of the Drug
Establishments during the initial and renewal application of their
LTO:
Has the Pharmacist or staff attended e-EDPMS Seminar
Has the pricelist been uploaded and updated regularly?
http://uhmis2.doh.gov.ph/eedpms
MDRP
- Maximum Drug Retail Price
- mandatory price reduction by EO 821 s 2009
2nd batch
- 93 more medicines and five medical devices were brought
down up to 70% off current retail prices
- For majority of products, the new price rate took effect on
March 31, 2010
- The new price rate for other products took effect on
August 1, 2010
ACTIVE
INGREDIENT/
MOLECULE
COMPANY
OLD
RETAIL
PRICE
GMAP
40mg tablet
Boehringer
51.50
25.75
Telmisartan 40mg +
Hydrochlorothiazide 12.5mg tablet
Boehringer
50.00
25.00
80mg tablet
Boehringer
89.00
44.50
Telmisartan 80mg +
Hydrochlorothiazide 12.5mg tablet
Boehringer
89.00
44.50
150mg tablet
Sanofi-Aventis
via Winthrop
48.76
24.38
Irbesartan 150mg +
Hydrochlorothiazide 12.5mg tablet
Sanofi-Aventis
via Winthrop
50.26
25.13
300mg tablet
Sanofi-Aventis
via Winthrop
80.00
40.00
Irbesartan 300mg +
Hydrochlorothiazide 12.5mg tablet
Sanofi-Aventis
via Winthrop
83.00
41.50
ANTIHYPERTENSIVE
1. Telmisartan
2. Irbesartan
ACTIVE
INGREDIENT/
MOLECULE
COMPANY
OLD
RETAIL
PRICE
GMAP
Sanofi-Aventis
123.50
61.75
Servier
15.00
7.50
80mg tablet
Servier
15.00
7.50
Wyeth
2175.46
730.20
Wyeth
4614.00
1270.06
ANTI-THROMBOTIC
3. Clopidogrel
ANTI-DIABETIC/ ANTIHYPOGLYCEMIC
4. Gliclazide
ANTIBIOTIC/ ANTIBACTERIAL
5. Piperacillin +
Tazobactam an
all its salt form
ACTIVE
INGREDIENT/
MOLECULE
COMPANY
OLD
RETAIL
PRICE
GMAP
500mg tablet
Bayer
83.83
41.91
Bayer
99.23
49.62
1g tablet
Bayer
145.10
72.55
250mg tablet
Bayer
65.13
32.57
Bayer
1884.17
942.00
Bayer
1440.87
720.43
Bayer
3207.17
1603.59
Sanofi-Aventis
131.00
65.50
500mg tablet
Sanofi-Aventis
via Winthrop
23.50
11.75
Sanofi-Aventis
379.50
189.75
ANTIBIOTIC/ ANTIBACTERIAL
6. Ciprofloxacin
and all its salt
form
7. Metronidazole
and all its salt
form
ACTIVE
INGREDIENT/
MOLECULE
COMPANY
OLD
RETAIL
PRICE
GMAP
625mg tablet
GSK
97.75
48.90
375mg tablet
GSK
79.50
39.75
1g tablet
GSK
142.25
71.15
GSK
687.50
343.75
GSK
1156.75
578.40
GSK
555.50
277.75
GSK
378.00
189.00
GSK
648.50
324.25
GSK
940.50
470.25
GSK
523.75
261.90
ANTIBIOTIC/ ANTIBACTERIAL
8. Co-Amoxiclav
(Amoxicillin +
Clavulanic
Acid)
ACTIVE INGREDIENT/
MOLECULE
DOSAGE
STRENGTH AND
FORM
COMPANY
OLD RETAIL
PRICE
GMAP
Bristol-Meyer
Squibb via Zuellig
9750.00
3520.00
10. Carboplatin
Bristol-Meyer
Squibb via Zuellig
3610.00
1805.00
11. Cisplatin
Bristol-Meyer
Squibb via Zuellig
2804.00
1125.00
50mg tablet
Bristol-Meyer
Squibb via Zuellig
33.50
17.50
Baxter
698.95
175.00
Bristol-Meyer
Squibb via Zuellig
649.00
324.50
Qualimed
1155.00
(most
expensive
brand)
577.50
ANTI-NEOPLASTICS/ ANTI-CANCER
12. Cyclophosphamide
ACTIVE INGREDIENT/
MOLECULE
DOSAGE
STRENGTH AND
FORM
COMPANY
OLD RETAIL
PRICE
GMAP
ANTI-NEOPLASTICS/ ANTI-CANCER
100mg tablet
Qualimed
1130.00
(most
expensive in
the market)
565.00
14. Mercaptopurine
50mg tablet
GSK
79.00
39.50
15. Methotrexate
Sodium (No
innovator locally)
2.5mg tablet
Qualimed
23.00 (most
expensive
brand)
11.00
Qualimed
612.00 (most
expensive
brand)
306.00
400mgampul for
injection
Baxter
369.00
166.67
16. Mesna
TRADE NAME
MANUFACTURER
1. Ezetrol
Ezetimibe
Schering-Plough
2. Vytorin
Ezetimibe + Simvastatin
MSD/Schering-Plough
Losartan +
Hydrochlorothiazide
MSD
4. Seroxat
Paroxetine
GlaxoSmithKline
5. Leponex
Clozapine
Novartis
6. Tykerb
Lapatinib
GlaxoSmithKline
7. Zoladex
Goserelin
AstraZeneca
3. Cozaar/ Hyzaar
TRADE NAME
MANUFACTURER
Goserelin
AstraZeneca
Asparaginase
Sanofi-Aventis
Salbutamol
GlaxoSmithKline
11. Coumadin
Warfarin
Bristol-Myers Squibb
12. Fraxiparine
Nadroparin
Sanofi-Aventis
13. Betopic
Betaxolol
Alcon Laboratories
14. Ciloxan
Ciprofloxacin
Alcon Laboratories
8. Zoladex LA
9. Leunase
TRADE NAME
MANUFACTURER
Pilocarpine
Alcon Laboratories
16. Quinax
Dihydroazapentacene
polysulfonate
Alcon Laboratories
17. Avodart
Dutasteride
GlaxoSmithKline
18. Revovir
Clevudine
Hi-Elsai
Pharmaceutical
Levofloxacin
Winthrop
Pharmaceuticals
Meloxicam
Winthrop
Pharmaceuticals
Fluticasone Propionate +
Salmeterol
GlaxoSmithKline
15. IsoptoCarpine
ACTIVE INGREDIENT/
MOLECULE
MDRP
(Php)
2.5mg tablet
9.60
5mg tablet
22.85
10mg tablet
38.50
34.45
ANTIHYPERTENSIVE
1. Amlodipine (includng
its S-isomer and salt
form)
ANTI-CHOLESTEROL
2. Atorvastatin
50.50
50.63
45.75
66.25
ACTIVE INGREDIENT/
MOLECULE
MDRP
(Php)
84.42
89.99
51.13
73.25
91.79
91.79
ANTI-CHOLESTEROL
2. Atorvastatin
ACTIVE INGREDIENT/
MOLECULE
MDRP
(Php)
ANTIBIOTIC/ ANTIBACTERIAL
3. Azithromycin and all
its Salt Form
250mg tablet
108.50
427.50
638.00
500mg tablet
151.43
992.50
2g granules
468.00
ACTIVE INGREDIENT/
MOLECULE
MDRP
(Php)
ANTI-NEOPLASTICS/ ANTI-CANCER
4. Cytarabine
240.00
900.00
1800.00
1980.00
1465.75
2265.74
AmendED:
RA 8293 - Intellectual Property
Code of the Philippines
AmendED:
RA 8293 - Intellectual Property
Code of the Philippines