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Last Updated: July 20, 2024

REQUIP XL Drug Patent 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.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Requip Xl

A generic version of REQUIP XL was approved as ropinirole hydrochloride by PRINSTON INC on May 5th, 2008.

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

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Recent Clinical Trials for REQUIP XL

Identify potential brand extensions & 505(b)(2) entrants

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

See all REQUIP XL clinical trials

Paragraph IV (Patent) Challenges for REQUIP XL
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

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 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-006 Apr 10, 2009 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-002 Jun 13, 2008 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-003 Jun 13, 2008 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-005 Oct 31, 2008 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-004 Jun 13, 2008 DISCN Yes 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 REQUIP XL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-006 Apr 10, 2009 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-002 Jun 13, 2008 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-002 Jun 13, 2008 ⤷  Sign Up ⤷  Sign Up
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 022008-001 Jun 13, 2008 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-003 Jun 13, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for REQUIP XL

See the table below for patents covering REQUIP XL around the world.

Country Patent Number Title Estimated Expiration
Denmark 1272167 ⤷  Sign Up
Canada 2031393 COMPRIMES A LIBERATION PROGRESSIVE DE SUBSTANCES ACTIVES (TABLETS WITH CONTROLLED-RATE RELEASE OF ACTIVE SUBSTANCES) ⤷  Sign Up
South Korea 20090094406 ⤷  Sign Up
European Patent Office 1272167 Forme posologique comprenant ropinirole a matrice polymère hydrophile/lipophile (Ropinirole-containing hydrophilic/liphilic polymeric matrix dosage formulation) ⤷  Sign Up
Italy 8922694 ⤷  Sign Up
Taiwan I224971 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for REQUIP XL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0299602 97C0036 Belgium ⤷  Sign Up 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 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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