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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-five suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Requip Xl

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

Summary for REQUIP XL

International Patents:	51
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	106
Clinical Trials:	35
Patent Applications:	1,187
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for REQUIP XL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REQUIP XL
DailyMed Link:	REQUIP XL at DailyMed

See drug prices for REQUIP XL

Recent Clinical Trials for REQUIP XL

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

Sponsor	Phase
Titan Pharmaceuticals	Phase 1/Phase 2
Vanderbilt University Medical Center	Phase 4
Seoul National University Hospital	Phase 4

See all REQUIP XL clinical trials

Recent Litigation for REQUIP XL

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ADAMAS PHARMA, LLC v. SANDOZ INC.	2018-05-10
Sanofi-Aventis v. Wockhardt Limited	2008-03-14
Plaintiff(s) v. Defendant(s)	2008-01-31

See all REQUIP XL litigation

Pharmacology for REQUIP XL

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine Agonists

Synonyms for REQUIP XL

030PYR8953

1,3-Dihydro-4-(2-(dipropylamino)ethyl)-2H-indol-2-one monohydrochloride

2(H)-Indol-2-one, 4-(2-(dipropylamino)ethyl)-1,3-dihydro-, monohydrochloride

2H-Indol-2-one, 1,3-dihydro-4-(2-(dipropylamino)ethyl)-, monohydrochloride

2H-Indol-2-one, 4-(2-(dipropylamino)ethyl)-1,3-dihydro-

2H-Indol-2-one,4-[2-(dipropylamino)ethyl]-1,3-dihydro-

374R208

374R219

4-(2-(Dipropylamino)ethyl)-1,3-dihydro-2H-indol-2-one

4-(2-(Dipropylamino)ethyl)-2-indolinone monohydrochloride

4-(2-(dipropylamino)ethyl)indolin-2-one

4-(2-(Dipropylamino)ethyl)indolin-2-one hydrochloride

4-(2-di-n-propylaminoethyl)-2(3H)-indolone hydrochloride

4-(2-di-n-propylaminoethyl)-2(3H)indolone hydrochloride

4-(2-dipropylaminoethyl)-1,3-dihydroindol-2-one

4-(2-dipropylaminoethyl)-1,3-dihydroindol-2-one hydrochloride

4-[2-(Di-n-propylamino)ethyl]-2(3H)-indolone Hydrochloride

4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one

4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one hydrochloride

4-[2-(Dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one; 4-[2-(Dipropylamino)ethyl]indoline-2-one; Ropinirole; SKF 101468

4-[2-(dipropylamino)ethyl]-1,3-dihydroindol-2-one

4-[2-(dipropylamino)ethyl]-1,3-dihydroindol-2-one hydrochloride

4-[2-(dipropylamino)ethyl]-1,3-dihydroindol-2-one;hydrochloride

4-[2-(dipropylamino)ethyl]-1.3-dihydro-2H-indol-2-one

4-[2-(dipropylamino)ethyl]-2,3-dihydro-1h-indol-2-one

4-[2-(dipropylamino)ethyl]-2,3-dihydro-1H-indol-2-one hydrochloride

4-[2-(dipropylamino)ethyl]-3H-indol-2-ol

4-[2-(Dipropylamino)ethyl]2-indolinone

4-[2-(dipropylamino)ethyl]indolin-2-one

4-[2-(dipropylamino)ethyl]indolin-2-one hydrochloride

4CA-1107

91374-20-8

91374-20-8 (hydrochloride)

91374-20-8,91374-21-9(freebase)

91374-21-9

91374-21-9 (base)

91374-21-9 (Parent)

A843815

AB0009822

AB01563044_01

AB01563044_02

AB1004799

ABP000199

AC-735

AC-736

AC1L1JLL

AC1L2ABS

AC1Q3EQJ

ACT02690

Adartrel

AJ-08123

AKOS015843123

AKOS015844988

AN-15583

AN-15584

ANW-58872

API0004095

BC207366

BC226368

BCP02130

BCP09383

BDBM50020680

BIDD:GT0826

BRD-K15933101-003-01-2

BS-1020

C-33038

C07564

CAS-91374-21-9

CC-34286

CCG-205177

CCG-213346

CHEBI:8888

CHEBI:8889

CHEMBL1200411

CHEMBL589

CS-2864

CTK8B7890

CTK8D4279

D00784

D08489

D7ZD41RZI9

DB00268

DSSTox_CID_25195

DSSTox_GSID_45195

DSSTox_RID_80742

DTXSID50238533

DTXSID8045195

EBD38503

EU-0101101

FC0024

FT-0642200

FT-0652500

GTPL7295

HMS2093K04

HP-3000

HSDB 8252

HY-B0623A

I06-0692

I06-0693

JZP-7

KB-80420

KS-000011L6

KS-00002WRZ

L000520

Lopac-R-4152

Lopac0_001101

LP01101

LS-83828

LS-83890

M-1298

MCULE-1333778454

MCULE-8190476072

MFCD01754173

MLS003899234

MolPort-003-666-598

MolPort-003-987-439

NCGC00015893-01

NCGC00015893-02

NCGC00015893-03

NCGC00015893-04

NCGC00015893-06

NCGC00094373-01

NCGC00096064-01

NCGC00096064-02

NCGC00261786-01

NP-201

NSC-758917

NSC758917

NVD-434

Pharmakon1600-01505178

R 4152

Repreve

Requi

ReQuip

Requip (TN)

ReQuip CR

ReQuip LP

ReQuip PR

ReQuip XR

ropinirol

Ropinirol [INN-Spanish]

ropinirole

Ropinirole (hydrochloride)

Ropinirole (USAN/INN)

Ropinirole [INN:BAN]

Ropinirole [USAN:INN:BAN]

Ropinirole for peak identification 1, EuropePharmacopoeia (EP) Reference Standard

Ropinirole for peak identification 2, EuropePharmacopoeia (EP) Reference Standard

Ropinirole HCl

Ropinirole hydrochloride

Ropinirole hydrochloride (JAN/USAN)

Ropinirole hydrochloride [USAN:USP]

Ropinirole hydrochloride [USAN]

Ropinirole hydrochloride, EuropePharmacopoeia (EP) Reference Standard

Ropinirole Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

Ropinirole hydrochloride, powder, >=98% (HPLC)

Ropinirole hydrochloride, United States Pharmacopeia (USP) Reference Standard

Ropinirole hydrochloride;

Ropinirole hydrochloride/

Ropinirolhydrochloride

Ropinirolum

Ropinirolum [INN-Latin]

Ropitor (TN)

s3189

SC-16286

SCHEMBL35212

SCHEMBL40760

SK&F 101468

SK&F 101468-A

SK&F-101,468

SK&F-101468

SK&F-101468-A

SK&F-101468A

SKF 101468

SKF 101468 hydrochloride

SKF 101468; 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one hydrochloride

SKF-101468

SKF-101468A

SMR001456484

SPECTRUM1505178

SR-01000076215

SR-01000076215-2

SR-01000076215-3

SR-01000076215-5

ST24042825

STL454344

SW199044-2

TC-010119

TC-030791

TL8005858

TL8005859

Tox21_110256

Tox21_110256_1

Tox21_501101

UHSKFQJFRQCDBE-UHFFFAOYSA-N

UNII-030PYR8953

UNII-D7ZD41RZI9

VA11691

XDXHAEQXIBQUEZ-UHFFFAOYSA-N

Z1695926158

ZINC2041

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

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
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-005	Oct 31, 2008
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-004	Jun 13, 2008
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-003	Jun 13, 2008

International Patents for REQUIP XL

Country	Patent Number	Estimated Expiration
South Korea	20030023859
Poland	202689
New Zealand	521902
Poland	365837
Australia	4857601
Cyprus	1108440
South Korea	20090094406

Supplementary Protection Certificates for REQUIP XL

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