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Amlodipine besylate; benazepril hydrochlorideis 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.
Summary for amlodipine besylate; benazepril hydrochloride
|Drug Master File Entries:||50|
|Suppliers / Packagers:||18|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for amlodipine besylate; benazepril hydrochloride|
|DailyMed Link:||amlodipine besylate; benazepril hydrochloride at DailyMed|
Recent Clinical Trials for amlodipine besylate; benazepril hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Shanghai Jiao Tong University School of Medicine||Phase 4|
|Novartis Pharmaceuticals||Phase 4|
|Dr. Reddy's Laboratories Limited||Phase 1|
Recent Litigation for amlodipine besylate; benazepril hydrochloride
Identify potential future generic entrants
District Court Litigation
|Edwards Lifesciences AG v. CoreValve, Inc.||2014-04-14|
|NOVARTIS PHARMACEUTICALS CORPORATION v. APOTEX INC.||2012-09-06|
|Pfizer Inc. v. Ranbaxy Laboratories Limited||2008-03-24|
Generic filers with tentative approvals for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for amlodipine besylate; benazepril hydrochloride
|Drug Class||Dihydropyridine Calcium Channel Blocker |
Angiotensin Converting Enzyme Inhibitor
|Mechanism of Action||Calcium Channel Antagonists |
Angiotensin-converting Enzyme Inhibitors
|Physiological Effect||Decreased Blood Pressure |
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