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Last Updated: November 2, 2024

FLECAINIDE ACETATE Drug Patent Profile


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When do Flecainide Acetate patents expire, and what generic alternatives are available?

Flecainide Acetate is a drug marketed by Amneal Pharm, Ani Pharms, Aurobindo Pharma Ltd, Beximco Pharms Usa, Chartwell, Hikma, Sun Pharm Inds Ltd, and Yichang Humanwell. and is included in nine NDAs.

The generic ingredient in FLECAINIDE ACETATE is flecainide acetate. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Flecainide Acetate

A generic version of FLECAINIDE ACETATE was approved as flecainide acetate by AMNEAL PHARM on July 31st, 2001.

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Drug patent expirations by year for FLECAINIDE ACETATE
Drug Prices for FLECAINIDE ACETATE

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Recent Clinical Trials for FLECAINIDE ACETATE

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

SponsorPhase
InCarda Therapeutics, Inc.Phase 3
InCarda Therapeutics, Inc.Phase 2
InCarda Therapeutics Australia Pty Ltd.Phase 2

See all FLECAINIDE ACETATE clinical trials

Pharmacology for FLECAINIDE ACETATE
Drug ClassAntiarrhythmic
Medical Subject Heading (MeSH) Categories for FLECAINIDE ACETATE
Anatomical Therapeutic Chemical (ATC) Classes for FLECAINIDE ACETATE

US Patents and Regulatory Information for FLECAINIDE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharm FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 075442-001 Jul 31, 2001 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 079164-003 Jul 9, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Ltd FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 076421-003 Mar 28, 2003 AB RX 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

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