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STALEVO 75 Drug Profile

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Stalevo 75 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 75 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 75

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

Clinical Trials for: STALEVO 75

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orion Pharma
STALEVO 75
carbidopa; entacapone; levodopa
TABLET;ORAL021485-005Aug 29, 2008RXNo6,500,867Jun 29, 2020Y
Orion Pharma
STALEVO 75
carbidopa; entacapone; levodopa
TABLET;ORAL021485-005Aug 29, 2008RXNo6,797,732Jun 29, 2020Y
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Expired Patents for Tradename: STALEVO 75

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma
STALEVO 75
carbidopa; entacapone; levodopa
TABLET;ORAL021485-005Aug 29, 20085,112,861<disabled>
Orion Pharma
STALEVO 75
carbidopa; entacapone; levodopa
TABLET;ORAL021485-005Aug 29, 20085,446,194<disabled>
Orion Pharma
STALEVO 75
carbidopa; entacapone; levodopa
TABLET;ORAL021485-005Aug 29, 20085,135,950<disabled>
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Paragraph IV activity for: STALEVO 75

Drugname Dosage Strength RLD Submissiondate
carbidopa, levodopa and entacaponeTablets18.75 mg/75 mg/200 mg and 31.25 mg/125 mg/200 mgStalevo 755/19/2009

International Patent Family for Tradename: STALEVO 75

Country Document Number Estimated Expiration
Finland991485<disabled in preview>
China1358090<disabled in preview>
Czech Republic304416<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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