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Ropinirole hydrochloride - Generic Drug Details

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What are the generic drug sources for ropinirole hydrochloride and what is the scope of ropinirole hydrochloride freedom to operate?

Ropinirole hydrochloride is the generic ingredient in three branded drugs marketed by Glaxosmithkline Llc, Actavis Elizabeth, Alembic Pharms Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz Inc, Watson Labs Inc, Wockhardt Ltd, Accord Hlthcare, Alembic Ltd, Apotex, Epic Pharma Llc, G And W Labs Inc, Glenmark Generics, Mylan, Orchid Hlthcare, Prinston Inc, West-ward Pharms Int, Wockhardt, and Zydus Pharms Usa Inc, and is included in twenty-one NDAs. There are two patents protecting this compound and nine Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ropinirole hydrochloride has fifty patent family members in twenty-seven countries.

There are fourteen drug master file entries for ropinirole hydrochloride. Thirty suppliers are listed for this compound.

Summary for ropinirole hydrochloride

International Patents:	50
US Patents:	2
Tradenames:	3
Applicants:	20
NDAs:	21
Drug Master File Entries:	14
Suppliers / Packagers:	30
Bulk Api Vendors:	96
Clinical Trials:	69
Patent Applications:	1,695
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ropinirole hydrochloride
DailyMed Link:	ropinirole hydrochloride at DailyMed

Pharmacology for ropinirole hydrochloride

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine Agonists

Synonyms for ropinirole hydrochloride

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 (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 ropinirole hydrochloride

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	022008-003	Jun 13, 2008	AB	RX	Yes	No			Y
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009	AB	RX	Yes	No			Y
Alembic Ltd	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	090429-007	Mar 24, 2010	AB	RX	No	No
Mylan	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	078881-004	May 5, 2008	AB	RX	No	No

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Expired US Patents for ropinirole hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-002	Sep 19, 1997
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-002	Sep 19, 1997
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-003	Sep 19, 1997

Non-Orange Book US Patents for ropinirole hydrochloride

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 ropinirole hydrochloride

Country	Document Number	Estimated Expiration
Australia	779623
Hungary	0300530
European Patent Office	1272167
Czech Republic	303943

Supplementary Protection Certificates for ropinirole hydrochloride

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
C/GB96/040	United Kingdom		PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702