PROPAFENONE HYDROCHLORIDE Drug Patent Profile
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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, Scinopharm Taiwan, Sinotherapeutics Inc, Strides Pharma, Upsher Smith Labs, Watson Labs Inc, Zydus, 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 24th, 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: | 1,156 |
Formulation / Manufacturing: | see details |
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 |
Pharmacology for PROPAFENONE HYDROCHLORIDE
Drug Class | Antiarrhythmic |
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 |