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Serving 500+ biopharmaceutical companies globally:

Express Scripts
McKesson
Fuji
Medtronic
Julphar
Fish and Richardson
Cerilliant
Citi
US Army
QuintilesIMS

Generated: September 25, 2017

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 five 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. Thirty suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for NDA: 020667

Tradename:
1
Applicant:
1
Ingredient:
1
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)

Summary for product number 001

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

Summary for product number 002

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

Expired Orange Book Patents for NDA: 020667



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Serving 500+ biopharmaceutical companies globally:

Moodys
US Department of Justice
Chinese Patent Office
Argus Health
Cipla
Healthtrust
McKinsey
Chubb
Daiichi Sankyo
Harvard Business School

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 verifification 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.

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