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Serving leading biopharmaceutical companies globally:

Deloitte
Harvard Business School
McKinsey
Julphar
Fish and Richardson
Farmers Insurance
Medtronic
Cerilliant
UBS
Healthtrust

Generated: November 20, 2017

DrugPatentWatch Database Preview

MIRAPEX Drug Profile

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What is the patent landscape for Mirapex, and when can generic versions of Mirapex launch?

Mirapex is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are four patents protecting this drug and five Paragraph IV challenges.

This drug has forty-one patent family members in twenty-five countries and one supplementary protection certificate in one country.

The generic ingredient in MIRAPEX is pramipexole dihydrochloride. There are twenty-four drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
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
pramipexole dihydrochloride
TABLET;ORAL020667-001Jul 1, 1997ABRXYesNo► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-003Feb 19, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-007Jun 17, 2011ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-007Jul 30, 2007ABRXYesNo► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-002Jul 1, 1997ABRXYesYes► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-005Jul 1, 1997ABRXYesNo► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-006Jun 17, 2011ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-007Jul 30, 2007ABRXYesNo► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-003Feb 19, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-005Feb 19, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for MIRAPEX

Drugname Dosage Strength RLD Submissiondate
pramipexole dihydrochlorideExtended-release Tablets2.25 mg and 3.75 mgMirapex ER7/26/2011
pramipexole dihydrochlorideExtended-release Tablets0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mgMirapex ER6/1/2010
pramipexole dihydrochlorideTablets0.75 mgMirapex7/31/2008
pramipexole dihydrochlorideTablets0.125 mg, 0.5 mg, 1 mg and 1.5 mgMirapex6/24/2005
pramipexole dihydrochlorideTablets0.25 mgMirapex5/27/2005

International Patent Family for Tradename: MIRAPEX

Country Document Number Estimated Expiration
Hungary226564► Subscribe
Slovenia0989850► Subscribe
Japan2001511158► Subscribe
Norway993360► Subscribe
Slovakia284264► Subscribe
Czech Republic9902478► Subscribe
China1117564► Subscribe
Denmark0989850► Subscribe
Japan2009062388► Subscribe
South Korea20000070234► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: MIRAPEX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB98/017United Kingdom► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Baxter
Colorcon
Chinese Patent Office
Queensland Health
Moodys
QuintilesIMS
Cipla
Citi
Teva

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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