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Generated: June 28, 2017
What are the generic drug sources for ropinirole hydrochloride and what is the scope of ropinirole hydrochloride freedom to operate?
Ropinirole hydrochloride is the generic ingredient in three branded drugs marketed by Glaxosmithkline Llc, Prinston Inc, Zydus Pharms Usa Inc, Accord Hlthcare, Alembic Ltd, Orchid Hlthcare, Epic Pharma Llc, Watson Labs Inc, Glenmark Generics, Sandoz Inc, Wockhardt, West-ward Pharms Int, G And W Labs Inc, Mylan Pharms Inc, Apotex, Actavis Elizabeth, Dr Reddys Labs Ltd, Mylan, Alembic Pharms Ltd, and Wockhardt Ltd, and is included in twenty-one NDAs. There are three patents protecting this compound and nine Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 3 |
| Patents: | 3 |
| Applicants: | 20 |
| NDAs: | 21 |
| Drug Master File Entries: see list | 14 |
| Suppliers / Packagers: see list | 33 |
| Bulk Api Vendors: see list | 67 |
| Clinical Trials: see list | 2,302 |
| Patent Applications: see list | 1,592 |
| Therapeutic Class: | Antiparkinson Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | ropinirole hydrochloride at DailyMed |
| Drug Class | Nonergot Dopamine Agonist |
| Mechanism of Action | Dopamine Agonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Wockhardt | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 079050-005 | May 29, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Accord Hlthcare | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 204022-003 | Feb 28, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Prinston Inc | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 078110-005 | May 5, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-006 | Jan 27, 1999 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Alembic Ltd | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 090429-005 | Mar 24, 2010 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-003 | Sep 19, 1997 | 4,824,860 | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-002 | Jun 13, 2008 | 5,422,123 | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-001 | Sep 19, 1997 | 4,824,860 | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-005 | Sep 19, 1997 | 4,824,860 | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-003 | Sep 19, 1997 | 4,452,808 | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,460,706 | Hydrophilic/lipophilic polymeric matrix dosage formulation | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Israel | 152184 | ► Subscribe | |||||||||||||||||||||||||||
| Hungary | 228269 | ► Subscribe | |||||||||||||||||||||||||||
| Czech Republic | 20023415 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 779623 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20070065922 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0036 | Belgium | ► Subscribe | PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702 | ||||||||||||||||||||||||||
| C/GB96/040 | United Kingdom | ► Subscribe | PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702 | ||||||||||||||||||||||||||
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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 verifification 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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