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Carbidopa; entacapone; levodopa - Generic Drug Details

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Carbidopa; entacapone; levodopa is the generic ingredient in seven branded drugs marketed by Wockhardt Ltd, Sun Pharma Global, and Orion Pharma, and is included in four NDAs. There are two patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-two patent family members in forty countries.

There are eighteen drug master file entries for carbidopa; entacapone; levodopa. Two suppliers are listed for this compound.

Summary for Generic Name: carbidopa; entacapone; levodopa

Tradenames:7
Patents:2
Applicants:3
NDAs:4
Drug Master File Entries: see list18
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details

Clinical Trials for: carbidopa; entacapone; levodopa

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global
CARBIDOPA, LEVODOPA AND ENTACAPONE
carbidopa; entacapone; levodopa
TABLET;ORAL079085-001May 10, 2012RXNo<disabled><disabled>
Orion Pharma
STALEVO 150
carbidopa; entacapone; levodopa
TABLET;ORAL021485-003Jun 11, 2003RXNo6,797,732<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 Orange Book Patents for Generic Ingredient: carbidopa; entacapone; levodopa

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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, 20035,112,861<disabled>
Orion Pharma
STALEVO 100
carbidopa; entacapone; levodopa
TABLET;ORAL021485-002Jun 11, 20035,446,194<disabled>
Orion Pharma
STALEVO 100
carbidopa; entacapone; levodopa
TABLET;ORAL021485-002Jun 11, 20034,963,590<disabled>
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International Patent Family for Ingredient: carbidopa; entacapone; levodopa

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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