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Ropinirole hydrochloride - Generic Drug Details
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What are the generic sources for ropinirole hydrochloride and what is the scope of freedom to operate?
Ropinirole hydrochloride
is the generic ingredient in three branded drugs marketed by Glaxosmithkline Llc, Actavis Elizabeth, Alembic Pharms Ltd, Celltrion, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz Inc, Watson Labs Inc, Accord Hlthcare, Alembic Ltd, Cadila, Cosette, Epic Pharma Llc, Glenmark Generics, Hikma, MLV, Mylan, Orchid Hlthcare, and Prinston Inc, and is included in twenty-one NDAs. There are two patents protecting this compound and nine Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Ropinirole hydrochloride has fifty-one patent family members in twenty-seven countries.
There are fourteen drug master file entries for ropinirole hydrochloride. Twenty-four suppliers are listed for this compound.
Summary for ropinirole hydrochloride
International Patents: | 51 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 19 |
NDAs: | 21 |
Drug Master File Entries: | 14 |
Suppliers / Packagers: | 24 |
Bulk Api Vendors: | 114 |
Clinical Trials: | 73 |
Patent Applications: | 1,905 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ropinirole hydrochloride at DailyMed |
Recent Clinical Trials for ropinirole hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Population Health Research Institute | Phase 3 |
University of Alberta | Phase 4 |
Titan Pharmaceuticals | Phase 1/Phase 2 |
Pharmacology for ropinirole hydrochloride
Drug Class | Nonergot Dopamine Agonist |
Mechanism of Action | Dopamine Agonists |
Paragraph IV (Patent) Challenges for ROPINIROLE HYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2009-07-14 |
REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2009-02-05 |
REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2009-01-08 |
REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2008-11-03 |
REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2008-10-31 |
REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2008-10-14 |
REQUIP | TABLET;ORAL | ropinirole hydrochloride | 020658 | 2005-02-04 |
REQUIP | TABLET;ORAL | ropinirole hydrochloride | 020658 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alembic Ltd | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 090429-002 | Mar 24, 2010 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Epic Pharma Llc | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 078230-005 | May 20, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-006 | Apr 10, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-003 | Jun 13, 2008 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Cadila | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 090411-004 | Jun 1, 2009 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Alembic Pharms Ltd | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202786-001 | Apr 22, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
>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 ropinirole hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-004 | Sep 19, 1997 | Start Trial | Start Trial |
Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-001 | Jun 13, 2008 | Start Trial | Start Trial |
Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-002 | Jun 13, 2008 | Start Trial | Start Trial |
Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-002 | Sep 19, 1997 | Start Trial | Start Trial |
Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-001 | Sep 19, 1997 | Start Trial | Start Trial |
Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-004 | Jun 13, 2008 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ropinirole hydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
Czech Republic | 303943 | Start Trial |
Israel | 152184 | Start Trial |
European Patent Office | 1681051 | Start Trial |
Spain | 2307608 | Start Trial |
South Africa | 200209226 | Start Trial |
Italy | 1318687 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ropinirole hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0299602 | 97C0036 | Belgium | Start Trial | PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702 |
0299602 | SPC/GB96/040 | United Kingdom | Start Trial | PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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