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Last Updated: July 13, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020667


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NDA 020667 describes MIRAPEX, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and five Paragraph IV challenges. Additional details are available on the MIRAPEX profile page.

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.
Summary for 020667
Tradename:MIRAPEX
Applicant:Boehringer Ingelheim
Ingredient:pramipexole dihydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020667
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 020667
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0101 0597-0101-90 90 TABLET in 1 BOTTLE (0597-0101-90)
MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0183 0597-0183-90 90 TABLET in 1 BOTTLE (0597-0183-90)
Paragraph IV (Patent) Challenges for 020667
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Jul 1, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 1, 1997TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jul 1, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020667

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-006 Feb 12, 1998   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-004 Jul 1, 1997   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

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