RYTHMOL SR Drug Patent Profile
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Which patents cover Rythmol Sr, and when can generic versions of Rythmol Sr launch?
Rythmol Sr is a drug marketed by Glaxosmithkline Llc and is included in one NDA.
The generic ingredient in RYTHMOL SR 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 Rythmol Sr
A generic version of RYTHMOL SR was approved as propafenone hydrochloride by WATSON LABS on October 24th, 2000.
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Summary for RYTHMOL SR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,032 |
| Drug Prices: | Drug price information for RYTHMOL SR |
| DailyMed Link: | RYTHMOL SR at DailyMed |
Recent Clinical Trials for RYTHMOL SR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 1 |
| Medtronic | Phase 3 |
| Mayo Clinic | Phase 3 |
Pharmacology for RYTHMOL SR
| Drug Class | Antiarrhythmic |
Paragraph IV (Patent) Challenges for RYTHMOL SR
| 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 RYTHMOL SR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | RYTHMOL SR | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021416-001 | Sep 4, 2003 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline Llc | RYTHMOL SR | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021416-002 | Sep 4, 2003 | DISCN | Yes | 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 | ||||
| >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 RYTHMOL SR
| 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 |
International Patents for RYTHMOL SR
See the table below for patents covering RYTHMOL SR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1120312 | ⤷ Sign Up | |
| Poland | 310966 | ⤷ Sign Up | |
| Israel | 109097 | ⤷ Sign Up | |
| Hungary | T73248 | ⤷ Sign Up | |
| Hungary | 9502879 | ⤷ Sign Up | |
| Denmark | 0691843 | ⤷ Sign Up | |
| European Patent Office | 0691843 | MICRO-COMPRIME RETARD DE DERIVES DE BETA-PHENYLPROPIOPHENONE (RETARDED-ACTION MICROTABLET MADE OF BETA-PHENYLPROPIOPHENONE DERIVATIVES) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated 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.
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