PROPAFENONE HYDROCHLORIDE - Generic Drug Details
✉ Email this page to a colleague
What are the generic 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, 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sinotherapeutics Inc | PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210339-002 | Jan 4, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Strides Pharma | PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078540-001 | Oct 18, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glaxosmithkline Llc | RYTHMOL SR | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021416-003 | Sep 4, 2003 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma | PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 202445-001 | May 11, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Upsher Smith Labs | PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 212744-002 | Jun 25, 2020 | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
