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Last Updated: January 19, 2021

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Ropinirole hydrochloride - Generic Drug Details

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What are the generic drug sources for ropinirole hydrochloride and what is the scope of patent protection?

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-three suppliers are listed for this compound.

Summary for ropinirole hydrochloride
Recent Clinical Trials for ropinirole hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Population Health Research InstitutePhase 3
University of AlbertaPhase 4
Titan PharmaceuticalsPhase 1/Phase 2

See all ropinirole hydrochloride clinical trials

Pharmacology for ropinirole hydrochloride
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine 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
Cadila ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 090411-002 Jun 1, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-004 Sep 19, 1997 AB RX Yes No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 090869-004 May 17, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 201576-002 Jun 6, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 202786-003 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 020658-001 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 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 ropinirole hydrochloride TABLET;ORAL 020658-004 Sep 19, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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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Serving leading biopharmaceutical companies globally:

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