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Carbidopa; levodopa - Generic Drug Details

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Carbidopa; levodopa is the generic ingredient in seven branded drugs marketed by Mayne Pharma, Impax Labs Inc, Apotex, Apotex Inc, Idt Australia Ltd, Impax Labs, Accord Hlthcare, Mylan, Sun Pharm Inds, Ranbaxy, Abbvie Inc, Merck Sharp Dohme, Actavis Elizabeth, Kv Pharm, SCS, Watson Labs, Sun Pharma Global, and Ucb Inc, and is included in twenty-nine NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-three patent family members in thirteen countries.

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

Summary for Generic Name: carbidopa; levodopa

Tradenames:7
Patents:8
Applicants:18
NDAs:29
Drug Master File Entries: see list18
Suppliers / Packagers: see list30
Clinical Trials: see list148
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:carbidopa; levodopa at DailyMed

Pharmacology for Ingredient: carbidopa; levodopa

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie Inc
DUOPA
carbidopa; levodopa
SUSPENSION;ENTERAL203952-001Jan 9, 2015RXYesYes► subscribe► subscribe
Sun Pharm Inds
CARBIDOPA AND LEVODOPA
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL077828-002Aug 23, 2007RXNoNo► subscribe► subscribe
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-004Jan 7, 2015RXYesYes► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: carbidopa; levodopa

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
SINEMET
carbidopa; levodopa
TABLET;ORAL017555-002Approved Prior to Jan 1, 19823,462,536► subscribe
Merck Sharp Dohme
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL019856-001May 30, 19913,830,827► subscribe
Merck Sharp Dohme
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL019856-001May 30, 19914,900,755► subscribe
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International Patent Family for Ingredient: carbidopa; levodopa

Country Document Number Estimated Expiration
European Patent Office1507518► subscribe
South Korea20100099731► subscribe
New Zealand602302► 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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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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