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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Farmers Insurance
Julphar
Argus Health
Cantor Fitzgerald
Accenture
Healthtrust
Teva
Merck
Johnson and Johnson

Generated: January 20, 2018

DrugPatentWatch Database Preview

MIRAPEX Drug Profile

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When do Mirapex patents expire, 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.

The generic ingredient in MIRAPEX is pramipexole dihydrochloride. There are twenty-four drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Drug patent expirations by year for MIRAPEX
Pharmacology for MIRAPEX
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists

US Patents and Regulatory Information for MIRAPEX

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;ORAL 020667-001 Jul 1, 1997 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-003 Feb 19, 2010 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-007 Jun 17, 2011 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-007 Jul 30, 2007 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-002 Jul 1, 1997 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-005 Jul 1, 1997 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-006 Jun 17, 2011 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-007 Jul 30, 2007 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-003 Feb 19, 2010 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-005 Feb 19, 2010 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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

Paragraph IV (Patent) Challenges for MIRAPEX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 2.25 mg and 3.75 mg ➤ Subscribe 7/26/2011
➤ Subscribe Extended-release Tablets 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg ➤ Subscribe 6/1/2010
➤ Subscribe Tablets 0.75 mg ➤ Subscribe 7/31/2008
➤ Subscribe Tablets 0.125 mg, 0.5 mg, 1 mg and 1.5 mg ➤ Subscribe 6/24/2005
➤ Subscribe Tablets 0.25 mg ➤ Subscribe 5/27/2005

International Patents for MIRAPEX

Supplementary Protection Certificates for MIRAPEX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB98/017 United Kingdom ➤ Subscribe 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 leading biopharmaceutical companies globally:

Federal Trade Commission
Julphar
Moodys
Medtronic
Teva
Citi
Fish and Richardson
Merck
Harvard Business School

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