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Generated: September 26, 2018

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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, 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-seven NDAs. There are four patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-four 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)-
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
➤ Try a Free Trial➤ Try a Free Trial4.5MGTABLET, EXTENDED RELEASE;ORAL
➤ Try a Free Trial➤ Try a Free Trial3MGTABLET, EXTENDED RELEASE;ORAL
➤ Try a Free Trial➤ Try a Free Trial1.5MGTABLET, 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
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-003 Feb 19, 2010 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Torrent Pharms PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090865-006 Oct 8, 2010 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 202633-004 Oct 26, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202353-001 Dec 4, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Alembic Pharms Ltd PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 078894-005 Oct 8, 2010 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 020667-003 Jul 1, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-003 Jul 1, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-002 Jul 1, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-001 Jul 1, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-001 Feb 19, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial 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:

Julphar
Argus Health
Fish and Richardson
AstraZeneca
Teva
US Department of Justice
McKesson
Federal Trade Commission
Chinese Patent Office

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