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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Chinese Patent Office
Fuji
Medtronic
Argus Health
Accenture
Moodys
Julphar

Generated: May 26, 2018

DrugPatentWatch Database Preview

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. Five 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 021540-002 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 200465-007 Nov 29, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-001 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 203874-004 Mar 7, 2014 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 021540-005 Jan 30, 2004 ➤ Sign Up ➤ Sign Up
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-002 Jan 30, 2004 ➤ Sign Up ➤ Sign Up
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-005 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
12/018 Ireland ➤ Sign Up 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
00478 Netherlands ➤ Sign Up 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
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
UBS
Cerilliant
Chubb
Fuji
Boehringer Ingelheim
Moodys
Medtronic
Harvard Business School

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