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Last Updated: June 13, 2024

ROPINIROLE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug 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 Pharms Ltd, 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
Hoffmann-La RochePhase 1
Population Health Research InstitutePhase 3
University of AlbertaPhase 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
Alembic Ltd ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 090429-003 Mar 24, 2010 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-007 Jan 27, 1999 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Prinston Inc ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 204413-003 May 11, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 079050-007 May 29, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Pharms Inc ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 200462-002 Oct 15, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-005 Oct 31, 2008 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-004 Jun 13, 2008 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-004 Sep 19, 1997 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-007 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.