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REQUIP XL

NDA

ROPINIROLE HYDROCHLORIDE | N022008 | GLAXOSMITHKLINE LLC

6 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from CellTrion, Inc. FDA-2020-P-1016 · 10 docket documents Celltrion, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Dr. Reddy's Laboratories Ltd's Ropinirole Hydrochloride Extended Release Tablets 2 mg (ANDA 201576) as an alternative reference standard for bioequivalence t	Other	2020-03-03	Withdrawn	CellTrion, Inc.
Lachman Consultant Services, Inc. - Citizen Petition FDA-2009-P-0170 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether Requip XL (ropinirole hydrochloride) Extended-release Tablets, 3 mg base (NDA 22-008), manufactured by SmithKline Beecham, was voluntarily withdrawn or withheld from sale for safety	505(q)	2009-04-03	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

56 trials from ClinicalTrials.gov, 49 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Impact of Switching to Continuous Release Dopamine Agonists NCT00465452	Phase 3	Completed	University of Toledo	11	2007-01 → 2011-12
Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food NCT00419692	Phase 1	Completed	GlaxoSmithKline	32	2006-08-24 → 2006-12-12
A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease NCT01494532	Phase 4	Completed	GlaxoSmithKline	352	2012-04-02 → 2014-11-18
Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fed Conditions NCT01714856	Phase 1	Completed	Lupin Ltd.	12	2008-09 → 2008-11
Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease NCT00823836	Phase 3	Completed	GlaxoSmithKline	302	2009-03 → 2010-12
Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression NCT00285727	N/A	Completed	Stanford University	60	2006-01 → 2007-10
Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148	Phase 2	Completed	GlaxoSmithKline	28	2007-04 → 2007-08
The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions NCT00830219	Phase 1	Completed	Teva Pharmaceuticals USA	46	2004-11 → 2004-11
Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fasting Conditions NCT01717235	Phase 1	Completed	Lupin Ltd.	12	2008-09 → 2008-11
Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome NCT00355641	Phase 3	Completed	GlaxoSmithKline	450	2005-10 → 2007-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain10 active DMFs4 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDROPINIROLE HYDROCHLORIDE

DMF 184122005

SYNTHIMED LABS PRIVATE LTDROPINIROLE HYDROCHLORIDE USP

DMF 185642005

TORRENT PHARMACEUTICALS LTDROPINIROLE HYDROCHLORIDE DRUG SUBSTANCE

DMF 187772005

USV PRIVATE LTDROPINIROLE HYDROCHLORIDE USP

DMF 190452005

NEULAND LABORATORIES LTDROPINIROLE HYDROCHLORIDE USP

DMF 195902006

ALEMBIC PHARMACEUTICALS LTDROPINIROLE HYDROCHLORIDE USP

DMF 197802006

ALIVUS LIFE SCIENCES LTDROPINIROLE HYDROCHLORIDE USP

DMF 205932007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDROPINIROLE HYDROCHLORIDE, USP

DMF 208292007

ORBION PHARMACEUTICALS PRIVATE LTDROPINIROLE HYDROCHLORIDE (NON-STERILE BULK API)

DMF 219382008

NEULAND LABORATORIES LTDROPINIROLE

DMF 264142012

URQUIMA SAInactiveROPINIROLE HYDROCHLORIDE

DMF 178802004

PCASInactiveROPINIROLE HYDROCHLORIDE

DMF 191982006

CADILA PHARMACEUTICALS LTDInactiveROPINIROLE HYDROCHLORIDE

DMF 199332006

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveROPINIROLE HYDROCHLORIDE USP

DMF 213312008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Jul 14, 2021	SUPPL -13	View Letter (PDF)
Jul 14, 2021	SUPPL -12	View Letter (PDF)
Mar 24, 2017	SUPPL -9	View Letter (PDF)
Sep 2, 2014	SUPPL -7	View Letter (PDF)
Sep 2, 2014	SUPPL -8	View Letter (PDF)
Sep 2, 2014	SUPPL -3	View Letter (PDF)
Sep 2, 2014	SUPPL -4	View Letter (PDF)
Apr 16, 2009	SUPPL -2	View Letter (PDF)
Nov 3, 2008	SUPPL -1	View Letter (PDF)
Jul 8, 2008	ORIG -1	View Letter (PDF)
Jun 20, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 13, 2008

No patent or exclusivity listings for this strength.

#002 — EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 13, 2008

#003 — EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 13, 2008

#004 — EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 13, 2008

#005 — EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 31, 2008

#006 — EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 10, 2009