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Last Updated: August 4, 2020

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FLECAINIDE ACETATE - Generic Drug Details

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What are the generic sources for flecainide acetate and what is the scope of freedom to operate?

Flecainide acetate is the generic ingredient in two branded drugs marketed by Amneal Pharm, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Hikma, Sun Pharm Inds Ltd, and Cnty Line Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for flecainide acetate. Twelve suppliers are listed for this compound.

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
Hikma FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 076278-001 Jan 14, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 075882-002 Oct 28, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-004 Aug 23, 1988 AB RX Yes No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 076030-001 Oct 28, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Amneal Pharm FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 075442-001 Jul 31, 2001 AB RX No No   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
>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 FLECAINIDE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-002 Oct 31, 1985   Start Trial   Start Trial
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-001 Oct 31, 1985   Start Trial   Start Trial
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-004 Aug 23, 1988   Start Trial   Start Trial
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-004 Aug 23, 1988   Start Trial   Start Trial
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-001 Oct 31, 1985   Start Trial   Start Trial
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-002 Oct 31, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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