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Last Updated: March 28, 2024

Propafenone hydrochloride - Generic Drug Details


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What are the generic drug sources for propafenone hydrochloride and what is the scope of freedom to operate?

Propafenone hydrochloride is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Mylan, Rising, Scinopharm Taiwan, Sinotherapeutics Inc, Strides Pharma, Upsher Smith Labs, Watson Labs Inc, Zydus, 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-one suppliers are listed for this compound.

Summary for propafenone hydrochloride
Recent Clinical Trials for propafenone hydrochloride

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

SponsorPhase
RenJi HospitalPhase 4
Rambam Health Care CampusEarly Phase 1
Rabin Medical CenterEarly Phase 1

See all propafenone hydrochloride clinical trials

Pharmacology for propafenone hydrochloride
Drug ClassAntiarrhythmic
Medical Subject Heading (MeSH) Categories for propafenone hydrochloride
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
Zydus PROPAFENONE HYDROCHLORIDE propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 214184-003 Apr 21, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs Inc PROPAFENONE HYDROCHLORIDE propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202688-002 Aug 24, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc RYTHMOL propafenone hydrochloride TABLET;ORAL 019151-003 Nov 20, 1992 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus PROPAFENONE HYDROCHLORIDE propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 214184-001 Apr 21, 2021 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 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 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-002 Sep 4, 2003 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-003 Sep 4, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.