ROPINIROLE HYDROCHLORIDE Drug Patent Profile
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When do Ropinirole Hydrochloride patents expire, and what generic alternatives are available?
Ropinirole Hydrochloride is a drug marketed by Actavis Elizabeth, Alembic, Chartwell Rx, Dr Reddys Labs Ltd, Mylan Pharms Inc, Prinston Inc, Sandoz Inc, Watson Labs Inc, Accord Hlthcare, Alembic Ltd, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Hikma, MLV, Norvium Bioscience, Orbion Pharms, and Zydus Lifesciences. and is included in twenty NDAs.
The generic ingredient in ROPINIROLE HYDROCHLORIDE is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ropinirole Hydrochloride
A generic version of ROPINIROLE HYDROCHLORIDE was approved as ropinirole hydrochloride by PRINSTON INC on May 5th, 2008.
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Questions you can ask:
- What is the 5 year forecast for ROPINIROLE HYDROCHLORIDE?
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Summary for ROPINIROLE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 18 |
| NDAs: | 20 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 136 |
| Clinical Trials: | 74 |
| Patent Applications: | 1,647 |
| DailyMed Link: | ROPINIROLE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ROPINIROLE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hoffmann-La Roche | Phase 1 |
| Population Health Research Institute | Phase 3 |
| University of Alberta | Phase 2 |
Pharmacology for ROPINIROLE HYDROCHLORIDE
| Drug Class | Nonergot Dopamine Agonist |
| Mechanism of Action | Dopamine Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ROPINIROLE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for ROPINIROLE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| REQUIP XL | Extended-release Tablets | ropinirole hydrochloride | 6 mg | 022008 | 1 | 2009-07-14 |
| REQUIP XL | Extended-release Tablets | ropinirole hydrochloride | 12 mg | 022008 | 1 | 2009-02-05 |
| REQUIP XL | Extended-release Tablets | ropinirole hydrochloride | 3 mg | 022008 | 1 | 2009-01-08 |
| REQUIP XL | Extended-release Tablets | ropinirole hydrochloride | 8 mg | 022008 | 1 | 2008-11-03 |
| REQUIP XL | Extended-release Tablets | ropinirole hydrochloride | 4 mg | 022008 | 1 | 2008-10-31 |
| REQUIP XL | Extended-release Tablets | ropinirole hydrochloride | 2 mg | 022008 | 1 | 2008-10-14 |
| REQUIP | Tablets | ropinirole hydrochloride | 3 mg, 4 mg and 5 mg | 020658 | 1 | 2005-02-04 |
| REQUIP | Tablets | ropinirole hydrochloride | 0.25 mg, 0.5 mg, 1 mg and 2 mg | 020658 | 1 | 2004-12-22 |
US Patents and Regulatory Information for ROPINIROLE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Epic Pharma Llc | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 078230-003 | May 20, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 078881-004 | May 5, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs Inc | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200431-005 | Jun 6, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz Inc | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201047-001 | Jun 6, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 077852-003 | May 5, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Prinston Inc | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 078110-003 | May 5, 2008 | 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 |
