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Serving leading biopharmaceutical companies globally:

US Army
Merck
Express Scripts
Cipla
AstraZeneca
Fuji
Daiichi Sankyo
Covington
McKesson
Fish and Richardson

Generated: January 17, 2018

DrugPatentWatch Database Preview

Ropinirole hydrochloride - Generic Drug Details

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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, Actavis Elizabeth, Alembic Pharms Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz Inc, Watson Labs Inc, Wockhardt Ltd, Accord Hlthcare, Alembic Ltd, Apotex, Epic Pharma Llc, G And W Labs Inc, Glenmark Generics, Mylan, Orchid Hlthcare, Prinston Inc, West-ward Pharms Int, Wockhardt, and Zydus Pharms Usa 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 patent family members in twenty-seven countries.

There are fourteen drug master file entries for ropinirole hydrochloride. Thirty-three suppliers are listed for this compound.
Summary for ropinirole hydrochloride
Pharmacology for ropinirole hydrochloride
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists

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
Apotex ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 079165-004 Feb 7, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs Inc ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 200431-004 Jun 6, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Wockhardt Ltd ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 091395-003 Aug 27, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Prinston Inc ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 078110-004 May 5, 2008 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 079165-005 Feb 7, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-004 Jun 13, 2008 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 077852-003 May 5, 2008 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-007 Jan 27, 1999 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Alembic Ltd ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 090429-004 Mar 24, 2010 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Accord Hlthcare ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 204022-003 Feb 28, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 020658-001 Sep 19, 1997 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-001 Jun 13, 2008 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-002 Sep 19, 1997 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-001 Sep 19, 1997 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-004 Sep 19, 1997 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-005 Sep 19, 1997 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-004 Sep 19, 1997 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-003 Sep 19, 1997 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-004 Jun 13, 2008 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-007 Jan 27, 1999 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for ropinirole hydrochloride

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
Patent No. Title Estimated Patent Expiration

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International Patents for ropinirole hydrochloride

Supplementary Protection Certificates for ropinirole hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
Teva
QuintilesIMS
Merck
Moodys
Harvard Business School
Boehringer Ingelheim
Chubb

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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