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Generated: April 22, 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, Alembic Pharms Ltd, Anchen Pharms, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Sandoz Inc, Zydus Pharms Usa Inc, Actavis Grp Ptc, Apotex Inc, Aurobindo Pharma Ltd, Barr, Breckenridge Pharm, Cspc Ouyi, Glenmark Generics, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Teva Pharms, Torrent Pharms, Unichem Labs Ltd, and Watson Labs, and is included in thirty NDAs. There are two 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 thirty patent family members in forty-four countries.

There are twenty-five drug master file entries for pramipexole dihydrochloride. Twenty-seven 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)-
2,6-Benzothiazolediamine, 4,5,6,7-tetrahydro-N6-propyl-,dihydrochloride, (6S)-
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
Mirapex
Mirapex ER
Mirapex LA
Mirapexin;Sifrol;Mirapex
MolPort-005-938-249
P2073
PPX dihydrochloride
Pramipexole hydrochloride
Pramipexole (dihydrochloride)
PRAMIPEXOLE 2HCL
Pramipexole diHCl
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
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
Anchen Pharms PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202206-007 Feb 6, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Anchen Pharms PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202206-004 Feb 6, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alembic Pharms Ltd PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 204518-002 Jan 2, 2019 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090151-002 Apr 30, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-003 Jul 1, 1997 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-007 Jun 17, 2011 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Actavis Grp Ptc PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 091254-005 Nov 30, 2010 DISCN 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 pramipexole dihydrochloride TABLET;ORAL 020667-007 Jul 30, 2007 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-005 Feb 19, 2010 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-004 Feb 19, 2010 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-002 Feb 19, 2010 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-007 Jul 30, 2007 ➤ 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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0186087 SPC/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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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