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Last Updated: August 8, 2020

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MIRAPEX Drug Profile

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When do Mirapex patents expire, and what generic alternatives are available?

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

The generic ingredient in MIRAPEX is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Drug patent expirations by year for MIRAPEX
Drug Prices for MIRAPEX

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Drug Sales Revenue Trends for MIRAPEX

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Recent Clinical Trials for MIRAPEX

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SponsorPhase
University of New MexicoEarly Phase 1
University of New Mexico Clinical and Translational Science CenterEarly Phase 1
The Zucker Hillside HospitalPhase 4

See all MIRAPEX clinical trials

Pharmacology for MIRAPEX
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists
Paragraph IV (Patent) Challenges for MIRAPEX
Tradename Dosage Ingredient NDA Submissiondate
MIRAPEX TABLET;ORAL pramipexole dihydrochloride 020667 2008-07-31
MIRAPEX TABLET;ORAL pramipexole dihydrochloride 020667 2005-06-24
MIRAPEX TABLET;ORAL pramipexole dihydrochloride 020667 2005-05-27

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   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-007 Jun 17, 2011 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-005 Jul 1, 1997 AB RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for MIRAPEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-007 Jul 30, 2007   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-006 Feb 12, 1998   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-002 Jul 1, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for MIRAPEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0186087 SPC/GB98/017 United Kingdom   Start 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
0186087 98C0013 Belgium   Start Trial PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014
0186087 C980002 Netherlands   Start Trial PRODUCT NAME: PRAMIPEXOL, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT, IN HET BIJZONDER PRAMIPEXOL-DIHYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/97/050/001 - EU/1/97/050/010 19971014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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