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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 is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-four patent family members in thirty-seven countries.

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

Summary for Generic Name: entacapone

Tradenames:2
Patents:1
Applicants:4
NDAs:4
Drug Master File Entries: see list18
Suppliers: see list10
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

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

Effect of Entacapone on Bodyweight Loss in Obese Population
Status: Recruiting Condition: Obesity

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

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

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

Entacapone Augmentation for Schizophrenia
Status: Completed Condition: Schizophrenia

Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off
Status: Completed Condition: Parkinson's 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
Mylan Pharms Inc
ENTACAPONE
entacapone
TABLET;ORAL202394-001May 13, 2013RXNo<disabled><disabled>
Sun Pharma Global
ENTACAPONE
entacapone
TABLET;ORAL090690-001Jul 16, 2012RXNo<disabled><disabled>
Orion Pharma
COMTAN
entacapone
TABLET;ORAL020796-001Oct 19, 1999RXYes6,599,530<disabled>Y<disabled>
Wockhardt Ltd
ENTACAPONE
entacapone
TABLET;ORAL078941-001Aug 16, 2012RXNo<disabled><disabled>
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International Patent Family for Ingredient: entacapone

Country Document Number Publication Date
China1319005Oct 24, 2001
Canada2342634Mar 23, 2000
Peru10602000Oct 20, 2000
Brazil9913681Jun 05, 2001
New Zealand510583Sep 27, 2002
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ISSN: 2162-2639

Preferred citation:

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

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