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Profile for Tradename: STALEVO 200

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Stalevo 200 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 200 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 200

Patents:2
Applicants:1
NDAs:1
Suppliers: see list6
Formulation / Manufacturing:see details

Clinical Trials for: STALEVO 200

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orion Pharma
STALEVO 200
carbidopa; entacapone; levodopa
TABLET;ORAL021485-004Aug 2, 2007RXYes6,500,867<disabled>Y<disabled>
Orion Pharma
STALEVO 200
carbidopa; entacapone; levodopa
TABLET;ORAL021485-004Aug 2, 2007RXYes6,797,732<disabled>Y<disabled>
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Paragraph IV activity for: STALEVO 200

Drugname Dosage Strength RLD Submissiondate
carbidopa, levodopa and entacaponeTablets50 mg/200 mg/200 mgStalevo 2008/28/2008

International Patent Family for Tradename: STALEVO 200

Country Document Number Publication Date
Japan4204783Jan 07, 2009
Poland352775Sep 08, 2003
ItalyMI20001450Jun 28, 2000
Portugal1189608Dec 31, 2003
Norway20016203Feb 25, 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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