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Profile for Tradename: STALEVO 125

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Stalevo 125 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 125 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 125

Suppliers / Packagers: see list60

Clinical Trials for: STALEVO 125

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

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

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

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: Recruiting Condition: Parkinson's Disease

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

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
carbidopa; entacapone; levodopa
TABLET;ORAL021485-006Aug 29, 2008RXNo6,500,867<disabled>Y <disabled>
Orion Pharma
carbidopa; entacapone; levodopa
TABLET;ORAL021485-006Aug 29, 2008RXNo6,797,732<disabled>Y <disabled>
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Paragraph IV activity for: STALEVO 125

Drugname Dosage Strength RLD Submissiondate
carbidopa, levodopa and entacaponeTablets18.75 mg/75 mg/200 mg and 31.25 mg/125 mg/200 mgStalevo 1255/19/2009

International Patent Family for Tradename: STALEVO 125

Country Document Number Publication Date
Hungary0202273Nov 28, 2002
TaiwanI241187Oct 11, 2005
Czech Republic20014636May 15, 2002
European Patent Office1189608Jul 23, 2003
Japan4885896Feb 29, 2012
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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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