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Generated: November 20, 2018

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AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - Generic Drug Details

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

Amlodipine besylate; benazepril hydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Par Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, and Novartis, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are fifty drug master file entries for amlodipine besylate; benazepril hydrochloride. Twenty-two suppliers are listed for this compound. There are two tentative approvals for this compound.

Pharmacology for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Tentative approvals for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up10MG; 20MGCAPSULE; ORAL
➤ Sign Up➤ Sign Up5MG; 20MGCAPSULE; ORAL
➤ Sign Up➤ Sign Up5MG; 10MGCAPSULE; ORAL

US Patents and Regulatory Information for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Pharms AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 078466-004 Feb 5, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 077375-001 May 21, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 091431-005 Dec 30, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Pharms AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 078466-005 Jul 5, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Inc AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 077183-003 Apr 15, 2010 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; BENAZEPRIL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-005 Jun 20, 2002 ➤ Sign Up ➤ Sign Up
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-007 Apr 11, 2006 ➤ Sign Up ➤ Sign Up
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-004 Mar 3, 1995 ➤ Sign Up ➤ Sign Up
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-002 Mar 3, 1995 ➤ Sign Up ➤ Sign Up
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-006 Apr 11, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
UBS
Deloitte
Boehringer Ingelheim
Covington
Colorcon
Accenture
Cipla
Medtronic

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