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STALEVO 50 Drug Profile

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Stalevo 50 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-two patent family members in forty countries.

The generic ingredient in STALEVO 50 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 50

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list6
Formulation / Manufacturing:see details
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 2003RXYes6,500,867► subscribeY ► subscribe
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 2003RXYes6,797,732► subscribeY ► subscribe
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Expired Patents for Tradename: STALEVO 50

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 20034,963,590► subscribe
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 20035,446,194► subscribe
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 20035,135,950► subscribe
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Paragraph IV activity for: STALEVO 50

Drugname Dosage Strength RLD Submissiondate
carbidopa, levodopa and entacaponeTablets12.5 mg, 50 mg and 200 mgStalevo 508/5/2008

International Patent Family for Tradename: STALEVO 50

Country Document Number Estimated Expiration
TaiwanI241187► subscribe
Slovakia19232001► subscribe
Brazil0011867► subscribe
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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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