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Profile for Tradename: STALEVO 50

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Stalevo 50 is a drug marketed by Orion Pharma and is included in one NDA. It is available from six suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in STALEVO 50 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for Tradename: STALEVO 50

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list60

Clinical Trials for: STALEVO 50

Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease
Status: Active, not recruiting Condition: Parkinson Disease; Sleep Disorders

Levodopa Concentration Profile With Stalevo 75/125 mg
Status: Completed Condition: Parkinson's Disease

Study to Evaluate Initiation of Stalevo in Early Wearing-off
Status: Completed Condition: Parkinson's Disease

Stalevo in Early Wearing-Off Patients
Status: Completed Condition: Idiopathic Parkinson's Disease

PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding
Status: Terminated Condition: Parkinson´s Disease

Pharmacokinetic Study With Repeated Doses of Stalevo
Status: Completed Condition: Pharmacokinetics

Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations
Status: Completed Condition: Parkinson's Disease

Adherence of Stalevo, Entacapone and Levodopa
Status: Completed Condition: Parkinson's Disease

Pharmacokinetic Study in Healthy Volunteers
Status: Completed Condition: Parkinson's Disease

Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens
Status: Completed Condition: Parkinson's Disease

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
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 2003RXYes6,500,867<disabled>Y <disabled>
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 2003RXYes6,797,732<disabled>Y <disabled>
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Expired Patents for Tradename: STALEVO 50

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 20034,963,590<disabled>
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 20035,112,861<disabled>
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 20035,135,950<disabled>
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Paragraph IV activity for: STALEVO 50

Drugname Dosage Strength RLD Submissiondate
carbidopa, levodopa and entacaponeTablets12.5 mg, 50 mg and 200 mgStalevo 508/5/2008

International Patent Family for Tradename: STALEVO 50

Country Document Number Publication Date
European Patent Office1189608Jul 23, 2003
Czech Republic303010Feb 29, 2012
Bulgaria106251Aug 30, 2002
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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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