Flecainide acetate - Generic Drug Details

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, 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. Fifteen 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:	15
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	5
Patent Applications:	1,148
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 Australia Pty Ltd.	Phase 2
InCarda Therapeutics, Inc.	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

Anatomical Therapeutic Chemical (ATC) Classes for flecainide acetate

C01BC	Antiarrhythmics, class Ic
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

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
Beximco Pharms Usa	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	210683-002	Sep 16, 2020	AB	RX	No	No
Chartwell	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	079164-001	Jul 9, 2009		DISCN	No	No
Sun Pharm Inds Ltd	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	076421-002	Mar 28, 2003	AB	RX	No	No
Ani Pharms	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	076030-003	Oct 28, 2002		DISCN	No	No
Yichang Humanwell	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	215599-002	Sep 8, 2022	AB	RX	No	No
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985		DISCN	Yes	No
Aurobindo Pharma Ltd	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	202821-002	Nov 3, 2017	AB	RX	No	No

Expired US Patents for flecainide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-004	Aug 23, 1988
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985