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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.

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: see list6
Formulation / Manufacturing:see details

Clinical Trials for: STALEVO 125

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

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

A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
Status: Completed Condition: Parkinson's Disease

Courtesy of
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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
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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