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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.

Amlodipine besylate; atorvastatin calcium has sixty-six patent family members in forty-six countries.

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
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-006 Jan 30, 2004 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 203874-005 Mar 7, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-004 Jan 30, 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 200465-010 Nov 29, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 200465-005 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 021540-008 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
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-008 Jan 30, 2004 ➤ Sign Up ➤ Sign Up
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-008 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
C/GB11/010 United Kingdom ➤ Sign Up PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
00499 Netherlands ➤ Sign Up 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
C0033 France ➤ Sign Up 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
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Moodys
McKinsey
Fish and Richardson
US Army
Colorcon
McKesson
Johnson and Johnson
US Department of Justice

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