PROPAFENONE HYDROCHLORIDE Drug Patent Profile

Which patents cover Propafenone Hydrochloride, and what generic alternatives are available?

Propafenone Hydrochloride is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Mylan, Rising, Sinotherapeutics Inc, Strides Pharma, Twi Pharms, Upsher Smith Labs, Watson Labs Inc, Zydus Lifesciences, Ani Pharms, Aurobindo Pharma, Nesher Pharms, Sun Pharm Industries, and Watson Labs. and is included in sixteen NDAs.

The generic ingredient in PROPAFENONE HYDROCHLORIDE is propafenone hydrochloride. There are eleven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Propafenone Hydrochloride

A generic version of PROPAFENONE HYDROCHLORIDE was approved as propafenone hydrochloride by WATSON LABS on October 24^th, 2000.

Summary for PROPAFENONE HYDROCHLORIDE

US Patents:	0
Applicants:	15
NDAs:	16
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	28
Patent Applications:	1,032
What excipients (inactive ingredients) are in PROPAFENONE HYDROCHLORIDE?	PROPAFENONE HYDROCHLORIDE excipients list
DailyMed Link:	PROPAFENONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PROPAFENONE HYDROCHLORIDE

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

Sponsor	Phase
RenJi Hospital	Phase 4
Rambam Health Care Campus	Early Phase 1
Rabin Medical Center	Early Phase 1

See all PROPAFENONE HYDROCHLORIDE clinical trials

Pharmacology for PROPAFENONE HYDROCHLORIDE

Drug Class

Antiarrhythmic

Medical Subject Heading (MeSH) Categories for PROPAFENONE HYDROCHLORIDE

Anti-Arrhythmia Agents

Voltage-Gated Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for PROPAFENONE HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for PROPAFENONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYTHMOL SR	Extended-release Capsules	propafenone hydrochloride	325 mg	021416	1	2006-11-07
RYTHMOL SR	Extended-release Capsules	propafenone hydrochloride	225 mg and 425 mg	021416	1	2006-10-11

US Patents and Regulatory Information for PROPAFENONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	TABLET;ORAL	075938-002	Oct 17, 2002	AB	RX	No	No
Ani Pharms	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	TABLET;ORAL	076550-002	Apr 23, 2004	AB	RX	No	No
Sun Pharm Industries	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	TABLET;ORAL	075998-003	Nov 29, 2001		DISCN	No	No
Zydus Lifesciences	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	214184-001	Apr 21, 2021	AB	RX	No	No
Ani Pharms	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	TABLET;ORAL	076550-003	Apr 23, 2004	AB	RX	No	No
Zydus Lifesciences	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	214184-002	Apr 21, 2021	AB	RX	No	No
Aurobindo Pharma Ltd	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	213096-001	Feb 21, 2023	AB	RX	No	No