Amlodipine besylate - Generic Drug Details
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What are the generic drug sources for amlodipine besylate and what is the scope of patent protection?
Amlodipine besylate
is the generic ingredient in nineteen branded drugs marketed by Cmp Dev Llc, Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Apotex, Aurobindo Pharma, Chartwell Rx, China Resources, Cipla, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan, Orbion Pharms, Oxford Pharms, Polygen Pharms, Puracap Pharm, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Torrent Pharms, Unichem, Upsher Smith Labs, Watson Labs, Wockhardt, Zydus Pharms Usa, Viatris, Dr Reddys, Zydus Pharms, Pharmacia, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Teva Pharms, Watson Labs Inc, Novartis, Purple Biotech, Par Pharm Inc, Teva Pharms Usa, Torrent, Daiichi Sankyo, Lupin Ltd, Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Micro Labs, Sciegen Pharms Inc, Adhera, Boehringer Ingelheim, and Novel Labs Inc, and is included in one hundred NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amlodipine besylate has five patent family members in five countries.
There are twenty-seven drug master file entries for amlodipine besylate. Fifty-two suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for amlodipine besylate
International Patents: | 5 |
US Patents: | 11 |
Tradenames: | 19 |
Applicants: | 63 |
NDAs: | 100 |
Drug Master File Entries: | 27 |
Finished Product Suppliers / Packagers: | 52 |
Raw Ingredient (Bulk) Api Vendors: | 114 |
Clinical Trials: | 56 |
Patent Applications: | 6,987 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) | Phase 4 |
American Society for Transplantation | Phase 4 |
Northwestern University | Phase 4 |
Generic filers with tentative approvals for AMLODIPINE BESYLATE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | EQ 10MG BASE | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | EQ 5MG BASE | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | EQ 2.5MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for amlodipine besylate
Drug Class | Dihydropyridine Calcium Channel Blocker 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 |
---|---|---|---|---|---|---|---|
Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-002 | Jul 31, 1992 | See Plans and Pricing | See Plans and Pricing |
Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-003 | Jul 31, 1992 | See Plans and Pricing | See Plans and Pricing |
Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-001 | Jul 31, 1992 | See Plans and Pricing | See Plans and Pricing |
Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-002 | Jul 31, 1992 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for amlodipine besylate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2002343257 | See Plans and Pricing | |
European Patent Office | 1448197 | See Plans and Pricing | |
World Intellectual Property Organization (WIPO) | 03043635 | See Plans and Pricing | |
Argentina | 037565 | FORMAS DE SALES DE AMLODIPINA Y PROCEDIMIENTOS PARA PREPARARLAS. | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for amlodipine besylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1507558 | C300528 | Netherlands | See Plans and Pricing | 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 |
1003503 | 05C0048 | France | See Plans and Pricing | 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 |
0443983 | C00443983/03 | Switzerland | See Plans and Pricing | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
0503785 | CA 2011 00026 | Denmark | See Plans and Pricing | PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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