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STALEVO 200 Drug Profile

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Stalevo 200 is a drug marketed by Orion Pharma and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-two 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. Two 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 / Packagers: see list1
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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Expired Patents for Tradename: STALEVO 200

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma
STALEVO 200
carbidopa; entacapone; levodopa
TABLET;ORAL021485-004Aug 2, 20075,112,861<disabled>
Orion Pharma
STALEVO 200
carbidopa; entacapone; levodopa
TABLET;ORAL021485-004Aug 2, 20075,446,194<disabled>
Orion Pharma
STALEVO 200
carbidopa; entacapone; levodopa
TABLET;ORAL021485-004Aug 2, 20075,135,950<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 Estimated Expiration
Poland352775<disabled in preview>
New Zealand515780<disabled in preview>
Yugoslavia92501<disabled in preview>
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