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STALEVO 100 Drug Profile

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Stalevo 100 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 100 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 100

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

Clinical Trials for: STALEVO 100

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orion Pharma
STALEVO 100
carbidopa; entacapone; levodopa
TABLET;ORAL021485-002Jun 11, 2003RXNo6,500,867<disabled>Y <disabled>
Orion Pharma
STALEVO 100
carbidopa; entacapone; levodopa
TABLET;ORAL021485-002Jun 11, 2003RXNo6,797,732<disabled>Y <disabled>
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Expired Patents for Tradename: STALEVO 100

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma
STALEVO 100
carbidopa; entacapone; levodopa
TABLET;ORAL021485-002Jun 11, 20034,963,590<disabled>
Orion Pharma
STALEVO 100
carbidopa; entacapone; levodopa
TABLET;ORAL021485-002Jun 11, 20035,135,950<disabled>
Orion Pharma
STALEVO 100
carbidopa; entacapone; levodopa
TABLET;ORAL021485-002Jun 11, 20035,112,861<disabled>
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Paragraph IV activity for: STALEVO 100

Drugname Dosage Strength RLD Submissiondate
carbidopa, levodopa and entacaponeTablets25/100/200 mg and 37.5/150/200 mgStalevo 1006/29/2007

International Patent Family for Tradename: STALEVO 100

Country Document Number Estimated Expiration
Georgia, Republic ofP20043314<disabled in preview>
Brazil0011867<disabled in preview>
France2797587<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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