AMLODIPINE BESYLATE Drug Patent Profile
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Which patents cover Amlodipine Besylate, and when can generic versions of Amlodipine Besylate launch?
Amlodipine Besylate is a drug marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Aurobindo Pharma, Chartwell Rx, China Resources, Cipla, Corepharma, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan, Norvium Bioscience, Orbion Pharms, Oxford Pharms, Polygen Pharms, Puracap Pharm, Sciegen Pharms Inc, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Torrent Pharms, Unichem, Watson Labs, Wockhardt, Zydus Pharms Usa, Apotex, Dr Reddys, Zydus Pharms, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Teva Pharms, Watson Labs Inc, Alembic, Hetero Labs, Novel Labs Inc, Teva Pharms Usa, Torrent, and Lupin Ltd. and is included in sixty-nine NDAs.
The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
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Summary for AMLODIPINE BESYLATE
US Patents: | 0 |
Applicants: | 52 |
NDAs: | 69 |
Finished Product Suppliers / Packagers: | 43 |
Raw Ingredient (Bulk) Api Vendors: | 125 |
Clinical Trials: | 58 |
Patent Applications: | 5,013 |
Drug Prices: | Drug price information for AMLODIPINE BESYLATE |
Drug Sales Revenues: | Drug sales revenues for AMLODIPINE BESYLATE |
What excipients (inactive ingredients) are in AMLODIPINE BESYLATE? | AMLODIPINE BESYLATE excipients list |
DailyMed Link: | AMLODIPINE BESYLATE at DailyMed |
Recent Clinical Trials for AMLODIPINE BESYLATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Overseas Pharmaceuticals, Ltd. | Phase 1 |
Guangzhou Health Start Pharmaceutical Techology Co.,Ltd | Phase 1 |
Northwestern University | Phase 4 |
Pharmacology for AMLODIPINE BESYLATE
Drug Class | Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker |
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE
US Patents and Regulatory Information for AMLODIPINE BESYLATE
Expired US Patents for AMLODIPINE BESYLATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Synthon Pharms | AMLODIPINE BESYLATE | amlodipine besylate | TABLET, ORALLY DISINTEGRATING;ORAL | 022026-001 | Sep 27, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Synthon Pharms | AMLODIPINE BESYLATE | amlodipine besylate | TABLET, ORALLY DISINTEGRATING;ORAL | 022026-003 | Sep 27, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Synthon Pharms | AMLODIPINE BESYLATE | amlodipine besylate | TABLET, ORALLY DISINTEGRATING;ORAL | 022026-002 | Sep 27, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMLODIPINE BESYLATE
See the table below for patents covering AMLODIPINE BESYLATE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2002343257 | ⤷ Sign Up | |
European Patent Office | 1448197 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 03043635 | ⤷ Sign Up | |
Norway | 20042539 | ⤷ Sign Up | |
Argentina | 037565 | FORMAS DE SALES DE AMLODIPINA Y PROCEDIMIENTOS PARA PREPARARLAS. | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMLODIPINE BESYLATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0443983 | C00443983/03 | Switzerland | ⤷ Sign Up | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
0503785 | C300486 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216 |
0443983 | 2007C/043 | Belgium | ⤷ Sign Up | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 |
1003503 | 05C0048 | France | ⤷ Sign Up | PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707 |
0502314 | SPC/GB11/010 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK |
1507558 | C300528 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |