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STALEVO 125 Drug Profile

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Stalevo 125 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 125 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 125

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details

Clinical Trials for: STALEVO 125

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orion Pharma
STALEVO 125
carbidopa; entacapone; levodopa
TABLET;ORAL021485-006Aug 29, 2008RXNo6,500,867<disabled>Y <disabled>
Orion Pharma
STALEVO 125
carbidopa; entacapone; levodopa
TABLET;ORAL021485-006Aug 29, 2008RXNo6,797,732<disabled>Y <disabled>
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Expired Patents for Tradename: STALEVO 125

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma
STALEVO 125
carbidopa; entacapone; levodopa
TABLET;ORAL021485-006Aug 29, 20085,112,861<disabled>
Orion Pharma
STALEVO 125
carbidopa; entacapone; levodopa
TABLET;ORAL021485-006Aug 29, 20085,446,194<disabled>
Orion Pharma
STALEVO 125
carbidopa; entacapone; levodopa
TABLET;ORAL021485-006Aug 29, 20085,135,950<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 Estimated Expiration
Yugoslavia92501<disabled in preview>
Poland197818<disabled in preview>
Finland991485<disabled in preview>
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