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Last Updated: December 4, 2020

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MIRAPEX ER Drug 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-four 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

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Drug Sales Revenue Trends for MIRAPEX ER

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Recent Clinical Trials for MIRAPEX ER

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

See all MIRAPEX ER clinical trials

Pharmacology for MIRAPEX ER
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists
Paragraph IV (Patent) Challenges for MIRAPEX ER
Tradename Dosage Ingredient NDA Submissiondate
MIRAPEX ER TABLET, EXTENDED RELEASE;ORAL pramipexole dihydrochloride 022421 2011-07-26
MIRAPEX ER TABLET, EXTENDED RELEASE;ORAL pramipexole dihydrochloride 022421 2010-06-01

US Patents and Regulatory Information for MIRAPEX ER

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   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-006 Jun 17, 2011 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-002 Feb 19, 2010 AB RX Yes No   Start Trial   Start Trial Y   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 ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-006 Jun 17, 2011 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-005 Feb 19, 2010 AB RX Yes No   Start Trial   Start Trial Y   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 ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-001 Feb 19, 2010   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-003 Feb 19, 2010   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-004 Feb 19, 2010   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-002 Feb 19, 2010   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-005 Feb 19, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for MIRAPEX ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0186087 98C0013 Belgium   Start Trial PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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