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Last Updated: February 27, 2020

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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 freedom to operate?

Ropinirole hydrochloride is the generic ingredient in three branded drugs marketed by Glaxosmithkline Llc, Actavis Elizabeth, Alembic Pharms Ltd, Celltrion, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz Inc, Watson Labs Inc, Accord Hlthcare, Acp Nimble, Alembic Ltd, Cadila, Epic Pharma Llc, Glenmark Generics, Hikma, MLV, Mylan, Orchid Hlthcare, and Prinston 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-one patent family members in twenty-seven countries.

There are fourteen drug master file entries for ropinirole hydrochloride. Twenty-five suppliers are listed for this compound.

Recent Clinical Trials for ropinirole hydrochloride

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

SponsorPhase
Population Health Research InstitutePhase 3
University of AlbertaPhase 4
Titan PharmaceuticalsPhase 1/Phase 2

See all ropinirole hydrochloride clinical trials

Recent Litigation for ropinirole hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
ADAMAS PHARMA, LLC v. SANDOZ INC.2018-05-10
Sanofi-Aventis v. Wockhardt Limited2008-03-14
Plaintiff(s) v. Defendant(s)2008-01-31

See all ropinirole hydrochloride litigation

Pharmacology for ropinirole hydrochloride
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine 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-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
AKOS015844988
AN-15584
ANW-58872
BC207366
BCP02130
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
Requi
ReQuip
Requip (TN)
ReQuip CR
ReQuip LP
ReQuip PR
ReQuip XL
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; Certified Reference Material
Ropinirole hydrochloride, powder, >=98% (HPLC)
Ropinirole hydrochloride, United States Pharmacopeia (USP) Reference Standard
Ropinirole hydrochloride;
Ropinirole hydrochloride/
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
SR-01000076215-5
ST24042825
SW199044-2
TC-030791
TL8005858
Tox21_501101
UNII-D7ZD41RZI9
XDXHAEQXIBQUEZ-UHFFFAOYSA-N
Z1695926158
Paragraph IV (Patent) Challenges for ROPINIROLE HYDROCHLORIDE
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
REQUIP TABLET;ORAL ropinirole hydrochloride 020658 2005-02-04
REQUIP TABLET;ORAL ropinirole hydrochloride 020658 2004-12-22

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
Cadila ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 090411-002 Jun 1, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 078881-004 May 5, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 200462-003 Oct 15, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz Inc ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 201047-006 Jun 6, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 204022-002 Feb 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>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 ropinirole hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-003 Sep 19, 1997   Start Trial   Start Trial
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-007 Jan 27, 1999   Start Trial   Start Trial
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-001 Jun 13, 2008   Start Trial   Start Trial
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-002 Jun 13, 2008   Start Trial   Start Trial
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-004 Sep 19, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ropinirole hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0299602 SPC/GB96/040 United Kingdom   Start Trial PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
0299602 97C0036 Belgium   Start Trial PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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