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Last Updated: May 21, 2022

MIRAPEX ER Drug Patent Profile


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Which patents cover Mirapex Er, and what generic alternatives are available?

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 thirty-two patent family members in forty-four countries.

The generic ingredient in MIRAPEX ER is pramipexole dihydrochloride. There are twenty-five 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.

Drug patent expirations by year for MIRAPEX ER
Drug Prices for MIRAPEX ER

See drug prices for MIRAPEX ER

Drug Sales Revenue Trends for MIRAPEX ER

See drug sales revenues for MIRAPEX ER

Recent Clinical Trials for MIRAPEX ER

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 ER clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for MIRAPEX ER
Paragraph IV (Patent) Challenges for MIRAPEX ER
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MIRAPEX ER Extended-release Tablets pramipexole dihydrochloride 2.25 mg and 3.75 mg 022421 1 2011-07-26
MIRAPEX ER Extended-release Tablets pramipexole dihydrochloride 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg 022421 1 2010-06-01

US Patents and Regulatory Information for MIRAPEX ER

MIRAPEX ER is protected by two US patents.

Patents protecting MIRAPEX ER

Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pramipexole once-daily dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-006 Jun 17, 2011 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-002 Feb 19, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-007 Jun 17, 2011 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 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 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-002 Feb 19, 2010 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-001 Feb 19, 2010 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-004 Feb 19, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for MIRAPEX ER

See the table below for patents covering MIRAPEX ER around the world.

Country Patent Number Title Estimated Expiration
Japan 2011084577 EXTENDED RELEASE TABLET FORMULATION CONTAINING PRAMIPEXOLE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, METHOD FOR MANUFACTURING THE SAME AND USE THEREOF See Plans and Pricing
Israel 166080 See Plans and Pricing
Hong Kong 78692 TETRAHYDROBENZOTHIAZOLES,THEIR PRODUCTION AND THEIR USE AS INTERMEDIATES OR DRUGS See Plans and Pricing
Japan 2011126916 EXTENDED RELEASE TABLET FORMULATION CONTAINING PRAMIPEXOLE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MIRAPEX ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0186087 98C0013 Belgium See Plans and Pricing PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014
0186087 SPC/GB98/017 United Kingdom See Plans and Pricing 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 C980002 Netherlands See Plans and Pricing 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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