amlodipine besylate Drug Patent Profile
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When do Amlodipine Besylate patents expire, and what generic alternatives are available?
Amlodipine Besylate is a drug marketed by Synthon Pharms, Accord Hlthcare, Aiping Pharm Inc, 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, 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, Watson Labs, Wockhardt, Zydus Pharms Usa, Apotex, Dr Reddys, Zydus Pharms, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, 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: | 50 |
NDAs: | 69 |
Finished Product Suppliers / Packagers: | 42 |
Raw Ingredient (Bulk) Api Vendors: | 125 |
Clinical Trials: | 58 |
Patent Applications: | 5,013 |
Formulation / Manufacturing: | see details |
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 |
![amlodipine besylate drug patent expirations Drug patent expirations by year for amlodipine besylate](/p/graph/s/t/amlodipine_besylate-patent-expirations.png)
![Drug Prices for amlodipine besylate](/p/graph/drug-price/amlodipine+besylate.png)
See drug prices for amlodipine besylate
![Drug Sales Revenue Trends for amlodipine besylate](/p/graph/drug-sales-revenues/amlodipine+besylate.png)
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 |
National Heart, Lung, and Blood Institute (NHLBI) | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Polygen Pharms | AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 207821-001 | Jul 11, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Strides Pharma | AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 090011-003 | Mar 28, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva | AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 076846-003 | Jun 28, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 |
---|---|---|---|
Norway | 20042539 | ⤷ Sign Up | |
Australia | 2002343257 | ⤷ Sign Up | |
European Patent Office | 1448197 | ⤷ 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 |
---|---|---|---|---|
1915993 | C300625 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414 |
0502314 | C300478 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |