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Last Updated: February 25, 2021

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Ropinirole hydrochloride - Generic Drug Details

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What are the generic 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 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 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-four 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
Suppliers / Packagers:	24
Bulk Api Vendors:	114
Clinical Trials:	73
Patent Applications:	1,905
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

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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
Alembic Ltd	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	090429-002	Mar 24, 2010	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Epic Pharma Llc	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	078230-005	May 20, 2008		DISCN	No	No	Start Trial	Start Trial				Start Trial
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009	AB	RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-003	Jun 13, 2008		DISCN	Yes	No	Start Trial	Start Trial	Y			Start Trial
Cadila	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	090411-004	Jun 1, 2009	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Alembic Pharms Ltd	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202786-001	Apr 22, 2013	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

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	ropinirole hydrochloride	TABLET;ORAL	020658-004	Sep 19, 1997	Start Trial	Start Trial
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-001	Jun 13, 2008	Start Trial	Start Trial
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008	Start Trial	Start Trial
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-002	Sep 19, 1997	Start Trial	Start Trial
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-001	Sep 19, 1997	Start Trial	Start Trial
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-004	Jun 13, 2008	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ropinirole hydrochloride

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Country	Patent Number	Estimated Expiration
Czech Republic	303943	Start Trial
Israel	152184	Start Trial
European Patent Office	1681051	Start Trial
Spain	2307608	Start Trial
South Africa	200209226	Start Trial
Italy	1318687	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ropinirole hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0299602	97C0036	Belgium	Start Trial	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	Start Trial	PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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