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Last Updated: July 12, 2020

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REQUIP XL Drug Profile


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When do Requip Xl patents expire, and when can generic versions of Requip Xl launch?

Requip Xl is a drug marketed by Glaxosmithkline Llc and is included in one NDA. There are two patents protecting this drug and seven Paragraph IV challenges.

This drug has fifty-one patent family members in twenty-seven countries.

The generic ingredient in REQUIP XL is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

Drug patent expirations by year for REQUIP XL
Drug Prices for REQUIP XL

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Recent Clinical Trials for REQUIP XL

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SponsorPhase
Titan PharmaceuticalsPhase 1/Phase 2
Vanderbilt University Medical CenterPhase 4
Seoul National University HospitalPhase 4

See all REQUIP XL clinical trials

Pharmacology for REQUIP XL
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists
Paragraph IV (Patent) Challenges for REQUIP XL
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

US Patents and Regulatory Information for REQUIP XL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-001 Jun 13, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-005 Oct 31, 2008 AB RX Yes No   Start Trial   Start Trial   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
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-002 Jun 13, 2008 DISCN Yes No   Start Trial   Start Trial Y   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   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
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-005 Oct 31, 2008 AB RX Yes No   Start Trial   Start Trial Y   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 REQUIP XL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 022008-006 Apr 10, 2009   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 XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-005 Oct 31, 2008   Start Trial   Start Trial
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-003 Jun 13, 2008   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

Supplementary Protection Certificates for REQUIP XL

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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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Moodys
Harvard Business School
Colorcon
Johnson and Johnson

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