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Generated: December 12, 2018

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Ropinirole hydrochloride - Generic Drug Details

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What are the generic 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.

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-(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
Wockhardt ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 079050-007 May 29, 2008 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Wockhardt Ltd ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 091395-002 Aug 27, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
G And W Labs Inc ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 077460-007 May 19, 2008 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Wockhardt ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 079050-005 May 29, 2008 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-002 Jun 13, 2008 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 078881-004 May 5, 2008 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ropinirole hydrochloride TABLET;ORAL 020658-001 Sep 19, 1997 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-003 Jun 13, 2008 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-002 Sep 19, 1997 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-001 Jun 13, 2008 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-003 Sep 19, 1997 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-004 Sep 19, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ropinirole hydrochloride

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

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
AstraZeneca
Merck
Fuji
Mallinckrodt
Citi
Chinese Patent Office
McKinsey

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