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Last Updated: March 28, 2024

AMLODIPINE MALEATE - Generic Drug Details


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What are the generic drug sources for amlodipine maleate and what is the scope of patent protection?

Amlodipine maleate is the generic ingredient in one branded drug marketed by Dr Reddys Labs Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for amlodipine maleate. There is one tentative approval for this compound.

Recent Clinical Trials for AMLODIPINE MALEATE

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

SponsorPhase
CSPC Ouyi Pharmaceutical Co., Ltd.Phase 1
Conjupro Biotherapeutics, Inc.Phase 1
Conjupro BiotherapeuticsPhase 1

See all AMLODIPINE MALEATE clinical trials

Generic filers with tentative approvals for AMLODIPINE MALEATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial10MG; 20MGCAPSULE; ORAL
⤷  Try a Trial⤷  Try a Trial5MG; 20MGCAPSULE; ORAL
⤷  Try a Trial⤷  Try a 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.

US Patents and Regulatory Information for AMLODIPINE MALEATE

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 AMVAZ amlodipine maleate TABLET;ORAL 021435-003 Oct 31, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Inc AMVAZ amlodipine maleate TABLET;ORAL 021435-002 Oct 31, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Inc AMVAZ amlodipine maleate TABLET;ORAL 021435-001 Oct 31, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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