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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Department of Justice
Colorcon
Farmers Insurance
Teva
UBS
Chubb
Medtronic
Merck
Julphar

Generated: January 17, 2018

DrugPatentWatch Database Preview

Amlodipine besylate - Generic Drug Details

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What are the generic drug sources for amlodipine besylate and what is the scope of amlodipine besylate freedom to operate?

Amlodipine besylate
is the generic ingredient in seventeen branded drugs 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, Pfizer, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Par Pharm, Teva Pharms, Watson Labs Inc, Novartis, Par Pharm Inc, Teva Pharms Usa, Torrent Pharms Ltd, Daiichi Sankyo, Lupin Ltd, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Micro Labs, Zydus Pharms Usa Inc, Symplmed Pharms Llc, Boehringer Ingelheim, and Novel Labs Inc, and is included in ninety-one NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate has four patent family members in four countries.

There are fifty drug master file entries for amlodipine besylate. Seventy-nine suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for amlodipine besylate
Pharmacology for amlodipine besylate
Tentative approvals for AMLODIPINE BESYLATE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe10MG; 20MGCAPSULE; ORAL
➤ Subscribe➤ Subscribe5MG; 20MGCAPSULE; ORAL
➤ Subscribe➤ Subscribe5MG; 10MGCAPSULE; ORAL

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
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-008 Jan 30, 2004 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sun Pharm Industries AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078081-002 Jan 31, 2008 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Alembic Pharms Ltd TELMISARTAN AND AMLODIPINE amlodipine besylate; telmisartan TABLET;ORAL 205234-004 Nov 17, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Lupin AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078043-003 Jul 12, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 200435-003 Sep 25, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 078381-006 Jul 29, 2010 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078224-001 Feb 27, 2008 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Dr Reddys Labs Ltd AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 203874-005 Mar 7, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Ajanta Pharma Ltd AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 207216-003 Oct 28, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sun Pharm Industries AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078081-003 Jan 31, 2008 DISCN 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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Expired US Patents for amlodipine besylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992 ➤ Subscribe ➤ Subscribe
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992 ➤ Subscribe ➤ Subscribe
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992 ➤ Subscribe ➤ Subscribe
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992 ➤ Subscribe ➤ Subscribe
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992 ➤ Subscribe ➤ Subscribe
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for amlodipine besylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
00445 Netherlands ➤ Subscribe PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
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
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
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
2011 00026 Denmark ➤ Subscribe 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
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
315 Luxembourg ➤ Subscribe PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
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
0443983/03 Switzerland ➤ Subscribe PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Chubb
Queensland Health
Federal Trade Commission
Medtronic
McKesson
Dow
Farmers Insurance
QuintilesIMS
Baxter

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