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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, Aurobindo Pharma Ltd, Mylan Pharms Inc, Sun Pharma Global, and Wockhardt Ltd, and is included in five 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 nineteen drug master file entries for entacapone. Ten suppliers are listed for this compound.

Summary for Generic Name: entacapone

Drug Master File Entries: see list19
Suppliers / Packaging: see list17
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

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

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

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

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

Courtesy of
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
Orion Pharma
TABLET;ORAL020796-001Oct 19, 1999RXYes6,599,530<disabled>Y <disabled>
Mylan Pharms Inc
TABLET;ORAL202394-001May 13, 2013RXNo<disabled><disabled>
Sun Pharma Global
TABLET;ORAL090690-001Jul 16, 2012RXNo<disabled><disabled>
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International Patent Family for Ingredient: entacapone

Country Document Number Publication Date
Indonesia29026Jul 26, 2001
Portugal1112065Apr 30, 2004
Norway331641Feb 13, 2012
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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