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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: see list6
Formulation / Manufacturing:see details

Clinical Trials for: STALEVO 50

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

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

An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)
Status: Completed Condition: Parkinson's Disease

Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
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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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
Hungary0202273Nov 28, 2002
TaiwanI241187Oct 11, 2005
Portugal1189608Dec 31, 2003
European Patent Office1189608Jul 23, 2003
Turkey200103763Apr 22, 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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