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Generated: January 18, 2019

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Pramipexole dihydrochloride - Generic Drug Details

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

Pramipexole dihydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Actavis Elizabeth, Anchen Pharms, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Sandoz Inc, Zydus Pharms Usa Inc, Actavis Grp Ptc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr, Breckenridge Pharm, Cspc Ouyi Pharm Co, Glenmark Generics, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Teva Pharms, Torrent Pharms, and Watson Labs, and is included in twenty-eight NDAs. There are four patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pramipexole dihydrochloride has two hundred and sixty-eight patent family members in fifty countries.

There are twenty-four drug master file entries for pramipexole dihydrochloride. Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for pramipexole dihydrochloride
Synonyms for pramipexole dihydrochloride
(6S)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine dihydrochloride
(6S)-N(6)-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine dihydrochloride
(6S)-N6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine dihydrochloride
(S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride
(S)-N6-Propyl-4,5,6,7-tetrahydrobenzo[d]-thiazole-2,6-diamine dihydrochloride
(S)-N6-Propyl-4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine dihydrochloride
(S)-N6-Propyl-4,5,6,7-tetrahydrobenzothiazole-2,6-diamine Dihydrochloride
(S)-Pramipexole Dihydrochloride
104632-25-9
112GI018
2,6-Benzothiazolediamine, 4,5,6,7-tetrahydro-N6-propyl-, dihydrochloride, (6S)-
2,6-Benzothiazolediamine, 4,5,6,7-tetrahydro-N6-propyl-, dihydrochloride, (S)-
4R2HD0M28N
632P259
AB0020076
AB2000575
AC-1040
AC1L3P1Q
AK-79154
AKOS005145770
AKOS015844953
AN-15614
ANW-57521
API0005552
BC215599
BG0440
BI-Sifrol
C10H19Cl2N3S
CCG-220987
CCG-222342
CHEBI:51148
CHEMBL3143955
CS-0890
CTK8B7511
DTXSID90146623
FD7210
FT-0601705
GS-3583
H32P260
HY-17355
J-001210
J-524051
KS-00000GZ2
KS-5081
LS-182448
MFCD00876894
Mirapex
Mirapex ER
Mirapex LA
Mirapexin;Sifrol;Mirapex
MolPort-005-938-249
P2073
PNU-98528E
PPX dihydrochloride
Pramipexole hydrochloride
Pramipexole (dihydrochloride)
PRAMIPEXOLE 2HCL
Pramipexole dihydrochloride [USAN]
Pramipexole dihydrochloride, >98% (HPLC), powder
PRAMIPEXOLE HYDROCHLORIDE
pramipexole hydrochloride anhydrous
QMNWXHSYPXQFSK-KLXURFKVSA-N
RTC-070954
SC-20191
SC-79550
SCHEMBL42113
SND-919CL2Y
SND-919Y
ST2402883
ST51051315
TC-070954
UNII-4R2HD0M28N
V0817
W-5189
Tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up4.5MGTABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up3MGTABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up1.5MGTABLET, EXTENDED RELEASE;ORAL

US Patents and Regulatory Information for pramipexole dihydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 077854-005 Oct 8, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alembic Pharms Ltd PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 078894-002 Oct 8, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cspc Ouyi Pharm Co PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 211088-004 Oct 3, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Inc PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 091683-006 Mar 27, 2013 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 pramipexole dihydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-007 Jul 30, 2007 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-003 Feb 19, 2010 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-001 Jul 1, 1997 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-002 Jul 1, 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 pramipexole dihydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB98/017 United Kingdom ➤ Sign Up PRODUCT NAME: PRAMIPEXOLE, OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT, IN PARTICULAR PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE; REGISTERED: UK EU/1/97/050/001 19971014; UK EU/1/97/050/002 19971014; UK EU/1/97/050/003 19971014; UK EU/1/97/050/004 19971014; UK EU/1/97/050/005 19971014; UK EU/1/97/050/006 19971014; UK EU/1/97/050/007 19971014; UK EU/1/97/050/008 19971014; UK EU/1/97/050/009 19971014; UK EU/1/97/050/010 19971014
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Fuji
Chinese Patent Office
Citi
Daiichi Sankyo
Fish and Richardson
Deloitte
Covington
Federal Trade Commission

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