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Serving leading biopharmaceutical companies globally:

UBS
Johnson and Johnson
Moodys
Covington
Boehringer Ingelheim
AstraZeneca
QuintilesIMS
US Department of Justice
Healthtrust
Daiichi Sankyo

Generated: January 18, 2018

DrugPatentWatch Database Preview

AMLODIPINE BESYLATE Drug 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, Alkem, Amneal Pharms Ny, Apotex, Aurobindo Pharma, China Resources, Cipla Ltd, Dr Reddys Labs Ltd, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Polygen Pharms, Puracap Pharm, Sandoz, Sovereign Pharms, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Unichem Labs Ltd, Upsher-smith Labs, Vintage, Vivimed Global, Watson Labs, West-ward Pharms Int, Wockhardt, Zydus Pharms Usa, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Par Pharm, Teva Pharms, Watson Labs Inc, Alembic Pharms Ltd, Novel Labs Inc, Par Pharm Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Lupin Ltd. and is included in sixty-four NDAs. There is one patent protecting this drug.

This drug has four patent family members in four countries.

The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Eight suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for AMLODIPINE BESYLATE
Drug patent expirations by year for AMLODIPINE BESYLATE
Pharmacology 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
Sun Pharm Inds Inc AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078231-001 Nov 30, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Torrent Pharms Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201593-001 Jun 3, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Vivimed Global AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 077516-003 Jul 11, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Invagen Pharms AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 206367-001 Dec 10, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gedeon Richter Usa AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 077333-002 Jul 17, 2007 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 078381-003 Jul 29, 2010 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Lupin Pharms AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 078466-004 Feb 5, 2010 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 076846-003 Jun 28, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Dr Reddys Labs Ltd AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 203874-001 Mar 7, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex Inc AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 091431-006 Dec 30, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Premature patent expiration for: AMLODIPINE BESYLATE

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
➤ Subscribe AMLODIPINE BESYLATE ➤ Subscribe

Supplementary Protection Certificates for AMLODIPINE BESYLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00528 Netherlands ➤ Subscribe 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
12/018 Ireland ➤ Subscribe PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
07C/043 Belgium ➤ Subscribe PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
00478 Netherlands ➤ Subscribe 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
00445 Netherlands ➤ Subscribe PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
C0033 France ➤ Subscribe 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: 6167801 20110705
00375 Netherlands ➤ Subscribe PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
00625 Netherlands ➤ Subscribe 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
C0048 France ➤ Subscribe 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
00499 Netherlands ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Argus Health
Express Scripts
Chubb
Novartis
Merck
Deloitte
Cantor Fitzgerald
Citi

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