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Profile for Tradename: MIRAPEX

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Summary for Tradename: MIRAPEX

Patents:4
Applicants:1
NDAs:2
Suppliers: see list5

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Status: Withdrawn Condition: Binge Eating Disorder

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

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

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

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

Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)
Status: Completed Condition: Amyotrophic Lateral Sclerosis

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

Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD
Status: Completed Condition: Parkinson Disease

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
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;ORAL020667Jul 1, 1997RXYes6,001,861<disabled><disabled>
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667Jul 30, 2007RXNo<disabled><disabled>
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421Feb 19, 2010RXYes7,695,734<disabled>Y<disabled>
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421Jun 17, 2011RXNo8,679,533<disabled>Y<disabled>
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667Jul 1, 1997RXNo6,001,861<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
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