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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
Drug Prices:see low prices

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
Orion Pharma
STALEVO 125
carbidopa; entacapone; levodopa
TABLET;ORAL021485-006Aug 29, 2008RXNo6,797,732Jun 29, 2020Y
Orion Pharma
STALEVO 200
carbidopa; entacapone; levodopa
TABLET;ORAL021485-004Aug 2, 2007RXYes6,797,732Jun 29, 2020Y
Orion Pharma
STALEVO 100
carbidopa; entacapone; levodopa
TABLET;ORAL021485-002Jun 11, 2003RXNo6,500,867Jun 29, 2020Y
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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 150
carbidopa; entacapone; levodopa
TABLET;ORAL021485-003Jun 11, 20035,135,950<disabled>
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 20034,963,590<disabled>
Orion Pharma
STALEVO 200
carbidopa; entacapone; levodopa
TABLET;ORAL021485-004Aug 2, 20075,135,950<disabled>
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International Patent Family for Ingredient: carbidopa; entacapone; levodopa

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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