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Generated: November 13, 2018

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 two suppliers. There are four 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-four drug master file entries for this compound. Twenty-seven 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:2
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Jul 1, 1997TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 16, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)
Patent:➤ Try a Free TrialPatent Expiration:Jan 16, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 1, 1997TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 16, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)

Expired US Patents for NDA 020667

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Harvard Business School
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