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Last Updated: November 21, 2019

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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 freedom to operate?

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

There are fifty drug master file entries for amlodipine besylate; benazepril hydrochloride. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for amlodipine besylate; benazepril hydrochloride

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SponsorPhase
Shanghai Jiao Tong University School of MedicinePhase 4
Novartis PharmaceuticalsPhase 4
Dr. Reddy's Laboratories LimitedPhase 1

See all amlodipine besylate; benazepril hydrochloride clinical trials

Recent Litigation for amlodipine besylate; benazepril hydrochloride

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District Court Litigation
Case NameDate
Edwards Lifesciences AG v. CoreValve, Inc.2014-04-14
NOVARTIS PHARMACEUTICALS CORPORATION v. APOTEX INC.2012-09-06
Pfizer Inc. v. Ranbaxy Laboratories Limited2008-03-24

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Generic filers with tentative approvals for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MG; 20MGCAPSULE; ORAL
  Start Trial  Start Trial5MG; 20MGCAPSULE; ORAL
  Start Trial  Start Trial5MG; 10MGCAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
LOTREL CAPSULE;ORAL amlodipine besylate; benazepril hydrochloride 020364 2006-11-17
LOTREL CAPSULE;ORAL amlodipine besylate; benazepril hydrochloride 020364 2004-06-09

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
Dr Reddys Labs Inc AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 090149-001 Jul 5, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 077179-004 May 18, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 077375-002 May 21, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-006 Apr 11, 2006 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 077375-004 May 21, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-004 Mar 3, 1995 AB RX Yes No   Start Trial   Start Trial   Start Trial
Par Pharm AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 078381-006 Jul 29, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for amlodipine besylate; benazepril hydrochloride

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