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Tradename: MIRAPEX

Summary for Tradename: MIRAPEX

Patents:4
Applicants:1
NDAs:2
Suppliers: see list5
drug
patent expirations by year for
 MIRAPEX

Pharmacology for Tradename: MIRAPEX

Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists

Clinical Trials for: MIRAPEX

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

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

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

A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period
Status: Completed Condition: Parkinson Disease

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

Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers
Status: Completed Condition: Healthy

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Status: Withdrawn Condition: Binge Eating Disorder

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

Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)
Status: Completed Condition: Parkinson Disease

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

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;ORAL020667Feb 12, 1998RXNo<disabled><disabled>
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667Feb 12, 1998RXNo6,001,861<disabled><disabled>
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667Feb 12, 1998RXNo6,194,445<disabled><disabled>
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667Jul 1, 1997DISCNNo<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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