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Profile for Tradename: MIRAPEX

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Mirapex 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.

This drug has thirty-eight patent family members in twenty-five countries.

The generic ingredient in MIRAPEX is pramipexole dihydrochloride. There are twenty-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for Tradename: MIRAPEX

Patents:4
Applicants:1
NDAs:2
Suppliers / Packagers: see list22

Pharmacology for Tradename: MIRAPEX

Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists

Clinical Trials for: MIRAPEX

Pramipexole as a Treatment for Cocaine Dependence
Status: Completed Condition: Cocaine Addiction; Cocaine Abuse; Cocaine Dependence; Substance Abuse

Pramipexole for Binge Eating Disorder
Status: Withdrawn Condition: Binge Eating Disorder

Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)
Status: Recruiting Condition: Parkinson's Disease

Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)
Status: Completed Condition: Amyotrophic Lateral Sclerosis

Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)
Status: Completed Condition: Amyotrophic Lateral Sclerosis

Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease
Status: Completed Condition: Parkinson Disease

Pramipexole Conversion to Ropinirole Controlled Release (CR)
Status: Completed Condition: Parkinson Disease

Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride
Status: Completed Condition: Bipolar Depression

Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor
Status: Not yet recruiting Condition: Essential Tremor

In Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets Pramipexole in Healthy Male Volunteers
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-001Jul 1, 1997RXNo6,001,861<disabled><disabled>
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-003Feb 19, 2010RXNo8,679,533<disabled>Y<disabled>
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-007Jun 17, 2011RXNo8,679,533<disabled>Y<disabled>
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-007Jul 30, 2007RXNo6,001,861<disabled><disabled>
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-002Jul 1, 1997RXYes6,194,445<disabled><disabled>
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Paragraph IV activity for: MIRAPEX

Drugname Dosage Strength RLD Submissiondate
pramipexole dihydrochlorideExtended-release Tablets2.25 mg and 3.75 mgMirapex ER7/26/2011
pramipexole dihydrochlorideExtended-release Tablets0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mgMirapex ER6/1/2010
pramipexole dihydrochlorideTablets0.75 mgMirapex7/31/2008
pramipexole dihydrochlorideTablets0.125 mg, 0.5 mg, 1 mg and 1.5 mgMirapex6/24/2005
pramipexole dihydrochlorideTablets0.25 mgMirapex5/27/2005

International Patent Family for Tradename: MIRAPEX

Country Document Number Publication Date
Slovenia989850Apr 30, 2005
Japan2009062388Mar 26, 2009
South Korea100761774Oct 04, 2007
Denmark0989850Dec 13, 2004
Canada2275379Jul 23, 1998
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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