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Last Updated: June 27, 2022

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 patent protection?

Amlodipine besylate; benazepril hydrochloride is the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Strides Pharma, 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.

Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for amlodipine besylate; benazepril hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

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

Generic filers with tentative approvals for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing10MG; 20MGCAPSULE; ORAL
See Plans and PricingSee Plans and Pricing5MG; 20MGCAPSULE; ORAL
See Plans and PricingSee Plans and Pricing5MG; 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 Strength NDA ANDAs Submitted Submissiondate
LOTREL Capsules amlodipine besylate; benazepril hydrochloride 5 mg/40 mg and 10 mg/40 mg 020364 1 2006-11-17
LOTREL Capsules amlodipine besylate; benazepril hydrochloride 2.5 mg/10 mg 5 mg/10 mg 5 mg/20 mg 10 mg/20 mg 020364 1 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
Apotex AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 091431-002 Dec 30, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 079047-002 Jul 5, 2011 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Strides Pharma AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 078381-006 Jul 29, 2010 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-007 Apr 11, 2006 See Plans and Pricing See Plans and Pricing
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-005 Jun 20, 2002 See Plans and Pricing See Plans and Pricing
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-002 Mar 3, 1995 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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