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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
US Army
McKesson
Covington
Medtronic
Johnson and Johnson
Baxter
Citi

Generated: April 23, 2018

DrugPatentWatch Database Preview

MIRAPEX ER Drug Profile

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When do Mirapex Er patents expire, and when can generic versions of Mirapex Er launch?

Mirapex Er is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and twenty-seven patent family members in forty-four countries.

The generic ingredient in MIRAPEX ER is pramipexole dihydrochloride. There are twenty-four drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Summary for MIRAPEX ER
Drug patent expirations by year for MIRAPEX ER
Pharmacology for MIRAPEX ER
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists
Synonyms for MIRAPEX ER
(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 LA
Mirapexin;Sifrol;Mirapex
MolPort-005-938-249
P2073
PNU-98528E
PPX dihydrochloride
Pramipexole hydrochloride
Pramipexole (dihydrochloride)
PRAMIPEXOLE 2HCL
Pramipexole dihydrochloride
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

US Patents and Regulatory Information for MIRAPEX ER

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 022421-001 Feb 19, 2010 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-006 Jun 17, 2011 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-002 Feb 19, 2010 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-007 Jun 17, 2011 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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 MIRAPEX ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-005 Feb 19, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-004 Feb 19, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-002 Feb 19, 2010 ➤ 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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Paragraph IV (Patent) Challenges for MIRAPEX ER
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 2.25 mg and 3.75 mg ➤ Subscribe 2011-07-26
➤ Subscribe Extended-release Tablets 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg ➤ Subscribe 2010-06-01

Non-Orange Book US Patents for MIRAPEX ER

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,377,977 Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof ➤ Try a Free Trial
8,399,016 Sustained-release tablet composition of pramipexole ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for MIRAPEX ER

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:

Farmers Insurance
Federal Trade Commission
Teva
Fish and Richardson
Accenture
Colorcon
Queensland Health
Johnson and Johnson
Medtronic

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