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, Norvium Bioscience, 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-four suppliers are listed for this compound.

Summary for ROPINIROLE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	19
NDAs:	22
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	74
Patent Applications:	2,622
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
Hoffmann-La Roche	Phase 1
Population Health Research Institute	Phase 3
University of Alberta	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	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Prinston Inc	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	078110-004	May 5, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Elizabeth	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090869-004	May 17, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	077460-001	May 5, 2008		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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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 XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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