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Last Updated: April 18, 2021

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ROPINIROLE HYDROCHLORIDE Drug 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 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 nineteen NDAs.

The generic ingredient in ROPINIROLE HYDROCHLORIDE is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-two 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 MYLAN on May 5th, 2008.

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Drug patent expirations by year for ROPINIROLE HYDROCHLORIDE
Recent Clinical Trials for ROPINIROLE HYDROCHLORIDE

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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
Epic Pharma Llc ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 078230-001 May 20, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 078881-002 May 5, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 204022-005 Feb 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs Inc ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 200431-001 Jun 6, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 077852-001 May 5, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Prinston Inc ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 078110-001 May 5, 2008 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

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