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Last Updated: March 29, 2024

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-one 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

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

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

See all Mirapex ER clinical trials

Pharmacology for Mirapex ER
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pramipexole once-daily dosage form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-006 Jun 17, 2011 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-002 Feb 19, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-007 Jun 17, 2011 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-006 Jun 17, 2011 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-005 Feb 19, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-005 Feb 19, 2010 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-003 Feb 19, 2010 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-002 Feb 19, 2010 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-004 Feb 19, 2010 ⤷  Try a Trial ⤷  Try a Trial
>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
Mexico PA05001056 COMPRIMIDO DE LIBERACION SOSTENIDA QUE COMPRENDE REBOXETINA. (SUSTAINED-RELEASE TABLET COMPRISING REBOXETINE.) ⤷  Try a Trial
Ireland 58863 Tetrahydro-benzthiazoles ⤷  Try a Trial
Brazil 0312891 Composição em comprimidos de liberação controlada compreendendo um agonista do receptor de dopamina ⤷  Try a Trial
Denmark 1531814 ⤷  Try a Trial
Spain 556874 ⤷  Try a Trial
Norway 20050093 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for Mirapex ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0186087 SPC/GB98/017 United Kingdom ⤷  Try a 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 C980002 Netherlands ⤷  Try a 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 ⤷  Try a Trial PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.