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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.

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

Summary for REQUIP XL

US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	96
Clinical Trials:	34
Patent Applications:	1,074
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

Pharmacology for REQUIP XL

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine Agonists

Synonyms for REQUIP XL

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

374R208

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

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

4-(2-(Dipropylamino)ethyl)indolin-2-onehydrochloride

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 hydrochloride

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

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

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

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

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

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

4CA-1107

91374-20-8

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

91374-21-9 (base)

91374-21-9 (Parent)

A843815

AB0009822

ABP000199

AC-735

AC-736

AC1L2ABS

AC1Q3EQJ

ACT02690

Adartrel

AK-59618

AKOS015844988

AN-15584

ANW-58872

BC207366

BS-1020

CCG-213346

CHEBI:8889

CHEMBL1200411

CS-2864

CTK8B7890

D00784

D7ZD41RZI9

DTXSID50238533

EBD38503

EU-0101101

FC0024

FT-0642200

HP-3000

HY-B0623A

I06-0693

JZP-7

KB-80420

KS-000011L6

KS-00002WRZ

LP01101

LS-83828

M-1298

MCULE-8190476072

MFCD01754173

MLS003899234

MolPort-003-987-439

NCGC00094373-01

NCGC00261786-01

NP-201

NVD-434

R 4152

Repreve

Requip (TN)

ReQuip LP

ReQuip PR

ReQuip XR

Ropinirole (hydrochloride)

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; traceable to USP, PhEur

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

Ropinirole hydrochloride, United States Pharmacopeia (USP) Reference Standard

Ropinirole hydrochloride;

Ropinirole hydrochloride/

Ropinirolehydrochloride

Ropinirolhydrochloride

s3189

SCHEMBL40760

SK&F 101468-A

SK&F-101468-A

SK&F-101468A

SKF 101468 hydrochloride

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

SKF-101468A

SMR001456484

SR-01000076215

SR-01000076215-2

ST24042825

ST51051236

TC-030791

TL8005858

Tox21_501101

UNII-D7ZD41RZI9

XDXHAEQXIBQUEZ-UHFFFAOYSA-N

Z1695926158

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	AB	RX	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	AB	RX	Yes	No			Y

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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	022008-005	Oct 31, 2008
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	022008-004	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

Paragraph IV (Patent) Challenges for REQUIP XL

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	3 mg
	Extended-release Tablets	6 mg
	Extended-release Tablets	12 mg
	Extended-release Tablets	3 mg
	Extended-release Tablets	8 mg
	Extended-release Tablets	4 mg
	Extended-release Tablets	2 mg

Non-Orange Book US Patents for REQUIP XL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,460,706	Hydrophilic/lipophilic polymeric matrix dosage formulation

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International Patents for REQUIP XL

Country	Document Number	Estimated Expiration
Hungary	0300530
Australia	4857601
Germany	60134964
Japan	5420207
Australia	779623
China	1427717

Supplementary Protection Certificates for REQUIP XL

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB96/040	United Kingdom		PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
C0036	Belgium		PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702