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Details for Generic Name: entacapone

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Entacapone is the generic ingredient in two branded drugs marketed by Orion Pharma, Mylan Pharms Inc, Sun Pharma Global, and Wockhardt Ltd, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for entacapone. Ten suppliers are listed for this compound.

Summary for Generic Name: entacapone

Drug Master File Entries: see list18
Suppliers: see list10
Therapeutic Class:Antiparkinson Agents

Pharmacology for Ingredient: entacapone

Clinical Trials for: entacapone

Augmenting Effects of L-DOPS With Carbidopa and Entacapone
Status: Terminated Condition: Parkinson Disease; Multiple System Atrophy; Autonomic Nervous System Diseases

COMT Polymorphism and Entacapone Efficacy
Status: Completed Condition: Parkinson's Disease

Pilot Study of Entacapone for Methamphetamine Abuse
Status: Recruiting Condition: Methamphetamine Dependence

Entacapone Augmentation for Schizophrenia
Status: Completed Condition: Schizophrenia

Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off
Status: Terminated Condition: Parkinson's Disease

Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off
Status: Completed Condition: Parkinson's Disease

Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers
Status: Completed Condition: Healthy

Courtesy of
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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt Ltd
TABLET;ORAL078941Aug 16, 2012RXNo<disabled><disabled>
Sun Pharma Global
TABLET;ORAL090690Jul 16, 2012RXNo<disabled><disabled>
Mylan Pharms Inc
TABLET;ORAL202394May 13, 2013RXNo<disabled><disabled>
Orion Pharma
TABLET;ORAL020796Oct 19, 1999RXYes6,599,530<disabled>Y<disabled>
Orion Pharma
TABLET;ORAL020796Oct 19, 1999RXYes5,446,194<disabled>Y<disabled>
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