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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 5^th, 2008.

Summary for ROPINIROLE HYDROCHLORIDE

US Patents:	0
Applicants:	18
NDAs:	19
Suppliers / Packagers:	22
Bulk Api Vendors:	116
Clinical Trials:	73
Patent Applications:	1,272
Formulation / Manufacturing:	see details
DailyMed Link:	ROPINIROLE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ROPINIROLE HYDROCHLORIDE

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

Sponsor	Phase
Population Health Research Institute	Phase 3
University of Alberta	Phase 4
Titan Pharmaceuticals	Phase 1/Phase 2

See all ROPINIROLE HYDROCHLORIDE clinical trials

Pharmacology for ROPINIROLE HYDROCHLORIDE

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine 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
Mylan	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	078881-002	May 5, 2008	AB	RX	No	No
Accord Hlthcare	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	204022-005	Feb 28, 2017	AB	RX	No	No
Watson Labs Inc	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200431-001	Jun 6, 2012		DISCN	No	No
Hikma	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	077852-001	May 5, 2008		DISCN	No	No
Prinston Inc	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	078110-001	May 5, 2008	AB	RX	No	No