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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Fish and Richardson
Mallinckrodt
Chinese Patent Office
McKesson
Deloitte
Federal Trade Commission
Daiichi Sankyo
AstraZeneca

Generated: October 21, 2018

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Amlodipine besylate; atorvastatin calcium - Generic Drug Details

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

Amlodipine besylate; atorvastatin calcium is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Ltd, Mylan Pharms Inc, and Pfizer, and is included in three NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are fifty drug master file entries for amlodipine besylate; atorvastatin calcium. Four suppliers are listed for this compound.

US Patents and Regulatory Information for amlodipine besylate; atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 203874-003 Mar 7, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 203874-002 Mar 7, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-011 Jul 29, 2004 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 200465-006 Nov 29, 2013 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

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Expired US Patents for amlodipine besylate; atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-004 Jan 30, 2004 ➤ Sign Up ➤ Sign Up
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-001 Jan 30, 2004 ➤ Sign Up ➤ Sign Up
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-006 Jan 30, 2004 ➤ Sign Up ➤ Sign Up
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-004 Jan 30, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for amlodipine besylate; atorvastatin calcium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
07C/043 Belgium ➤ Sign Up PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0443983/03 Switzerland ➤ Sign Up PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
00528 Netherlands ➤ Sign Up 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
00486 Netherlands ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Fish and Richardson
Mallinckrodt
Chinese Patent Office
McKesson
Deloitte
Federal Trade Commission
Daiichi Sankyo
AstraZeneca

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