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Last Updated: March 18, 2024

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, 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 Generics, Hikma, MLV, Mylan, Orbion Pharms, and Zydus Lifesciences, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for ropinirole hydrochloride. Twenty-five 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 2
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 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
Accord Hlthcare ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 204022-002 Feb 28, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 091395-001 Aug 27, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mlv ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 079165-004 Feb 7, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-005 Sep 19, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Ltd ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 201576-001 Jun 6, 2012 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-003 Jun 13, 2008 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-003 Sep 19, 1997 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-006 Jan 27, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-001 Jun 13, 2008 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-001 Sep 19, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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