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Last Updated: November 22, 2024

Propafenone hydrochloride - Generic Drug Details


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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

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
Anatomical Therapeutic Chemical (ATC) Classes 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
Rising PROPAFENONE HYDROCHLORIDE propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205956-002 Jul 2, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Industries PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET;ORAL 075998-001 Nov 29, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET;ORAL 202445-002 May 11, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Industries PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET;ORAL 075998-002 Nov 29, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Lifesciences PROPAFENONE HYDROCHLORIDE propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 214184-002 Apr 21, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-003 Sep 4, 2003 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-002 Sep 4, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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