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Last Updated: October 14, 2024

MIRAPEX Drug Patent 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 three Paragraph IV challenges.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Mirapex

A generic version of MIRAPEX was approved as pramipexole dihydrochloride by ZYDUS PHARMS USA INC on July 6th, 2010.

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Summary for MIRAPEX
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 279
Clinical Trials: 32
Patent Applications: 29
Drug Prices: Drug price information for MIRAPEX
What excipients (inactive ingredients) are in MIRAPEX?MIRAPEX excipients list
DailyMed Link:MIRAPEX at DailyMed
Drug patent expirations by year for MIRAPEX
Drug Prices for MIRAPEX

See drug prices for MIRAPEX

Drug Sales Revenue Trends for MIRAPEX

See drug sales revenues for MIRAPEX

Recent Clinical Trials for MIRAPEX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Massachusetts General HospitalPhase 2/Phase 3
University of New MexicoEarly Phase 1
University of New Mexico Clinical and Translational Science CenterEarly Phase 1

See all MIRAPEX clinical trials

Paragraph IV (Patent) Challenges for MIRAPEX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MIRAPEX Tablets pramipexole dihydrochloride 0.75 mg 020667 1 2008-07-31
MIRAPEX Tablets pramipexole dihydrochloride 0.125 mg, 0.5 mg, 1 mg and 1.5 mg 020667 1 2005-06-24
MIRAPEX Tablets pramipexole dihydrochloride 0.25 mg 020667 1 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 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-007 Jun 17, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-005 Jul 1, 1997 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 020667-002 Jul 1, 1997 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-003 Jul 1, 1997 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-007 Jul 30, 2007 ⤷  Sign Up ⤷  Sign Up
>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 98C0013 Belgium ⤷  Sign Up PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014
0186087 C980002 Netherlands ⤷  Sign Up 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
0186087 SPC/GB98/017 United Kingdom ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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