amlodipine besylate Drug Patent Profile
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Which patents cover Amlodipine Besylate, 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, 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.
Summary for amlodipine besylate
US Patents: | 0 |
Applicants: | 49 |
NDAs: | 69 |
Finished Product Suppliers / Packagers: | 42 |
Raw Ingredient (Bulk) Api Vendors: | 125 |
Clinical Trials: | 58 |
Patent Applications: | 5,382 |
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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Strides Pharma | AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 090011-003 | Mar 28, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva | AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 076846-003 | Jun 28, 2007 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 | 022026-003 | Sep 27, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Synthon Pharms | AMLODIPINE BESYLATE | amlodipine besylate | TABLET, ORALLY DISINTEGRATING;ORAL | 022026-001 | Sep 27, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Synthon Pharms | AMLODIPINE BESYLATE | amlodipine besylate | TABLET, ORALLY DISINTEGRATING;ORAL | 022026-002 | Sep 27, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 | ⤷ Try a Trial | |
Australia | 2002343257 | ⤷ Try a Trial | |
European Patent Office | 1448197 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for amlodipine besylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0678503 | C300499 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114 |
1507558 | 12C0033 | France | ⤷ Try a Trial | PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705 |
0503785 | C300486 | Netherlands | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |