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Last Updated: March 28, 2024

ROPINIROLE HYDROCHLORIDE Drug Patent Profile


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When do Ropinirole Hydrochloride patents expire, and what generic alternatives are available?

Ropinirole Hydrochloride is a drug marketed by 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 NDAs.

The generic ingredient in ROPINIROLE HYDROCHLORIDE is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ropinirole Hydrochloride

A generic version of ROPINIROLE HYDROCHLORIDE was approved as ropinirole hydrochloride by PRINSTON INC on May 5th, 2008.

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Drug patent expirations by year 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
Anatomical Therapeutic Chemical (ATC) Classes for ROPINIROLE HYDROCHLORIDE
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
Epic Pharma Llc ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 078230-003 May 20, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 078881-004 May 5, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs Inc ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 200431-005 Jun 6, 2012 DISCN No No ⤷  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

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