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Details for Generic Name: carbidopa; entacapone; levodopa

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Carbidopa; entacapone; levodopa is the generic ingredient in seven branded drugs marketed by Sun Pharma Global, Wockhardt Ltd, and Orion Pharma, and is included in four NDAs. There are two patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-one patent family members in forty countries.

There are eighteen drug master file entries for carbidopa; entacapone; levodopa. Six suppliers are listed for this compound.

Summary for Generic Name: carbidopa; entacapone; levodopa

Tradenames:7
Patents:2
Applicants:3
NDAs:4
Drug Master File Entries: see list18
Suppliers / Packaging: see list60

Clinical Trials for: carbidopa; entacapone; levodopa

Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
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

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

Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off
Status: Withdrawn Condition: Parkinson's Disease

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

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

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

Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease
Status: Completed Condition: Parkinson's Disease With End of Dose "Wearing Off"

Courtesy of ClinicalTrials.org
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
Wockhardt Ltd
CARBIDOPA, LEVODOPA AND ENTACAPONE
carbidopa; entacapone; levodopa
TABLET;ORAL090833-005Nov 20, 2012RXNo<disabled><disabled>
Orion Pharma
STALEVO 100
carbidopa; entacapone; levodopa
TABLET;ORAL021485-002Jun 11, 2003RXNo6,797,732<disabled>Y <disabled>
Orion Pharma
STALEVO 150
carbidopa; entacapone; levodopa
TABLET;ORAL021485-003Jun 11, 2003RXNo6,797,732<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: carbidopa; entacapone; levodopa

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma
STALEVO 150
carbidopa; entacapone; levodopa
TABLET;ORAL021485-003Jun 11, 20035,135,950<disabled>
Orion Pharma
STALEVO 200
carbidopa; entacapone; levodopa
TABLET;ORAL021485-004Aug 2, 20075,112,861<disabled>
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 20035,446,194<disabled>
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International Patent Family for Ingredient: carbidopa; entacapone; levodopa

Country Document Number Publication Date
Norway330260Mar 14, 2011
World Intellectual Property Organization (WIPO)0101984Jan 11, 2001
Yugoslavia92501Sep 03, 2004
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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.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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