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Ropinirole hydrochloride - Generic Drug Details

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What are the generic drug sources for ropinirole hydrochloride and what is the scope of patent protection?

Ropinirole hydrochloride is the generic ingredient in three branded drugs marketed by Glaxosmithkline Llc, 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, Orbion Pharms, and Prinston Inc, and is included in twenty-one NDAs. There are two patents protecting this compound and nine Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ropinirole hydrochloride has fifty-one patent family members in twenty-seven countries.

There are fourteen drug master file entries for ropinirole hydrochloride. Twenty-two suppliers are listed for this compound.

Summary for ropinirole hydrochloride

International Patents:	51
US Patents:	2
Tradenames:	3
Applicants:	19
NDAs:	21
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	73
Patent Applications:	2,771
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in ropinirole hydrochloride?	ropinirole hydrochloride excipients list
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 2
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

Anatomical Therapeutic Chemical (ATC) Classes for ropinirole hydrochloride

N04BC	Dopamine agonists
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

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
Mylan	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	078881-004	May 5, 2008	AB	RX	No	No
Mlv	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	079165-001	Feb 7, 2012	AB	RX	No	No
Orbion Pharms	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	079229-002	Nov 28, 2012	AB	RX	No	No
Alembic Pharms Ltd	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202786-002	Apr 22, 2013	AB	RX	No	No
Celltrion	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	079050-001	May 29, 2008	AB	RX	No	No

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	020658-003	Sep 19, 1997
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-001	Jun 13, 2008
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-004	Sep 19, 1997
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-004	Jun 13, 2008

International Patents for ropinirole hydrochloride

Country	Patent Number	Estimated Expiration
Germany	60134964
Australia	2009230759
South Korea	20070065922
Hong Kong	1053602
Mexico	PA02010151

Supplementary Protection Certificates for ropinirole hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0299602	97C0036	Belgium		PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702
0299602	SPC/GB96/040	United Kingdom		PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702