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, 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 24th, 2000.
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Questions you can ask:
- What is the 5 year forecast for PROPAFENONE HYDROCHLORIDE?
- What are the global sales for PROPAFENONE HYDROCHLORIDE?
- What is Average Wholesale Price for PROPAFENONE HYDROCHLORIDE?
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 |
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ani Pharms | PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 076550-002 | Apr 23, 2004 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm Industries | PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 075998-003 | Nov 29, 2001 | DISCN | 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 |
