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Last Updated: January 28, 2022

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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

SponsorPhase
Population Health Research InstitutePhase 3
University of AlbertaPhase 2
Titan PharmaceuticalsPhase 1/Phase 2

See all ropinirole hydrochloride clinical trials

Pharmacology for ropinirole hydrochloride
Drug Class Nonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists
Anatomical Therapeutic Chemical (ATC) Classes for ropinirole hydrochloride
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 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Mlv ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 079165-001 Feb 7, 2012 AB RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Orbion Pharms ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 079229-002 Nov 28, 2012 AB RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Alembic Pharms Ltd ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 202786-002 Apr 22, 2013 AB RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Celltrion ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 079050-001 May 29, 2008 AB RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free 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

Supplementary Protection Certificates for ropinirole hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0299602 97C0036 Belgium ⤷  Sign up for a Free 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 ⤷  Sign up for a Free 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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Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Express Scripts
Johnson and Johnson
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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.