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Last Updated: September 20, 2020

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FLECAINIDE ACETATE Drug 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 Inc, Apotex Inc, Aurobindo Pharma Ltd, Hikma, and Sun Pharm Inds Ltd. and is included in seven NDAs.

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

US ANDA 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

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SponsorPhase
InCarda Therapeutics Australia Pty Ltd.Phase 2
MEDA Pharma GmbH & Co. KGPhase 4

See all FLECAINIDE ACETATE clinical trials

Pharmacology for FLECAINIDE ACETATE
Drug ClassAntiarrhythmic
Medical Subject Heading (MeSH) Categories for FLECAINIDE ACETATE
Paragraph IV (Patent) Challenges for FLECAINIDE ACETATE
Tradename Dosage Ingredient NDA Submissiondate
TAMBOCOR TABLET;ORAL flecainide acetate 018830

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   Start Trial   Start Trial   Start Trial
Hikma FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 076278-003 Jan 14, 2003 AB RX No Yes   Start Trial   Start Trial   Start Trial
Ani Pharms Inc FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 076030-002 Oct 28, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 075882-001 Oct 28, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 079164-003 Jul 9, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 076421-002 Mar 28, 2003 AB RX No No   Start Trial   Start Trial   Start 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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