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Last Updated: April 19, 2024

Flecainide acetate - Generic Drug Details

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What are the generic drug sources for flecainide acetate and what is the scope of patent protection?

Flecainide acetate is the generic ingredient in two branded drugs marketed by Amneal Pharm, Ani Pharms, Aurobindo Pharma Ltd, Beximco Pharms Usa, Chartwell, Hikma, Sun Pharm Inds Ltd, Yichang Humanwell, and Alvogen, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for flecainide acetate

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	10
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	5
Patent Applications:	1,148
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for flecainide acetate
What excipients (inactive ingredients) are in flecainide acetate?	flecainide acetate excipients list
DailyMed Link:	flecainide acetate at DailyMed

See drug prices for flecainide acetate

Recent Clinical Trials for flecainide acetate

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

Sponsor	Phase
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 Class	Antiarrhythmic

Medical Subject Heading (MeSH) Categories for flecainide acetate

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

US Patents and Regulatory Information for flecainide acetate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	202821-002	Nov 3, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Inds Ltd	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	076421-002	Mar 28, 2003	AB	RX	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

Expired US Patents for flecainide acetate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-004	Aug 23, 1988	⤷ Try a Trial	⤷ Try a Trial
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985	⤷ Try a Trial	⤷ Try a Trial
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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