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Last Updated: November 2, 2024

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 Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Norvium Bioscience, Strides Pharma, Teva Pharms, Watson Labs, Watson Labs Inc, and Sandoz, 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.

Summary for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
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
⤷  Sign Up⤷  Sign Up5MG; 10MGCAPSULE; ORAL
⤷  Sign Up⤷  Sign Up2.5MG; 10MGCAPSULE; ORAL
⤷  Sign Up⤷  Sign Up10MG; 20MGCAPSULE; 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
Dr Reddys Labs Inc AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 090149-001 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 090149-002 Jul 5, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 077375-004 May 21, 2010 DISCN 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

Expired US Patents for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-002 Mar 3, 1995 ⤷  Sign Up ⤷  Sign Up
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-004 Mar 3, 1995 ⤷  Sign Up ⤷  Sign Up
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-002 Mar 3, 1995 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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