Propafenone hydrochloride - Generic Drug Details

What are the generic sources for propafenone hydrochloride and what is the scope of patent protection?

Propafenone hydrochloride is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Mylan, Rising, Sinotherapeutics Inc, Strides Pharma, Twi Pharms, Upsher Smith Labs, Watson Labs Inc, Zydus Lifesciences, Glaxosmithkline Llc, Ani Pharms, Aurobindo Pharma, Nesher Pharms, Sun Pharm Industries, and Watson Labs, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for propafenone hydrochloride. Twenty suppliers are listed for this compound.

Summary for propafenone hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	16
NDAs:	18
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	28
Patent Applications:	2,032
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
Sinotherapeutics Inc	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210339-002	Jan 4, 2019	AB	RX	No	No
Strides Pharma	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078540-001	Oct 18, 2010	AB	RX	No	No
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-003	Sep 4, 2003		DISCN	Yes	No
Aurobindo Pharma	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	TABLET;ORAL	202445-001	May 11, 2016	AB	RX	No	No
Upsher Smith Labs	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212744-002	Jun 25, 2020	AB	RX	No	No
Nesher Pharms	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	TABLET;ORAL	076193-001	Feb 7, 2002		DISCN	No	No
Watson Labs	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	TABLET;ORAL	075203-001	Oct 24, 2000	AB	RX	No	No

Expired US Patents for propafenone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-001	Sep 4, 2003
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-003	Sep 4, 2003
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-002	Sep 4, 2003