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Last Updated: May 8, 2021

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Carbidopa; entacapone; levodopa - Generic Drug Details

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What are the generic sources for carbidopa; entacapone; levodopa and what is the scope of patent protection?

Carbidopa; entacapone; levodopa is the generic ingredient in seven branded drugs marketed by Mylan, Sun Pharm, Wockhardt Ltd, and Orion Pharma, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for carbidopa; entacapone; levodopa

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
TFS Trial Form SupportPhase 1
LobSor Pharmaceuticals ABPhase 1
Asan Medical CenterN/A

See all carbidopa; entacapone; levodopa clinical trials

Pharmacology for carbidopa; entacapone; levodopa
Paragraph IV (Patent) Challenges for CARBIDOPA; ENTACAPONE; LEVODOPA
Tradename Dosage Ingredient NDA Submissiondate
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 150 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 150 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 150 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 150 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29

US Patents and Regulatory Information for carbidopa; entacapone; levodopa

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485-005 Aug 29, 2008 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Mylan CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 203424-006 Aug 13, 2020 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Orion Pharma STALEVO 125 carbidopa; entacapone; levodopa TABLET;ORAL 021485-006 Aug 29, 2008 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Wockhardt Ltd CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 090786-001 Nov 20, 2012 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for carbidopa; entacapone; levodopa

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Serving leading biopharmaceutical companies globally:

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