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Last Updated: March 28, 2024

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, Rising, Sun Pharm, Wockhardt Ltd, and Orion Pharma, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Recent Clinical Trials for carbidopa; entacapone; levodopa

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

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

See all carbidopa; entacapone; levodopa clinical trials

Pharmacology for carbidopa; entacapone; levodopa

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 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wockhardt Ltd CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 090833-005 Nov 20, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Orion Pharma STALEVO 150 carbidopa; entacapone; levodopa TABLET;ORAL 021485-003 Jun 11, 2003 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma STALEVO 150 carbidopa; entacapone; levodopa TABLET;ORAL 021485-003 Jun 11, 2003 ⤷  Try a Trial ⤷  Try a Trial
Orion Pharma STALEVO 50 carbidopa; entacapone; levodopa TABLET;ORAL 021485-001 Jun 11, 2003 ⤷  Try a Trial ⤷  Try a Trial
Orion Pharma STALEVO 150 carbidopa; entacapone; levodopa TABLET;ORAL 021485-003 Jun 11, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for carbidopa; entacapone; levodopa

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Orion Corporation Levodopa/Carbidopa/Entacapone Orion levodopa, carbidopa, entacapone EMEA/H/C/002441
Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.
Authorised no no no 2011-08-23
Orion Corporation Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) levodopa, carbidopa, entacapone EMEA/H/C/002785
Corbilta is indicated for the treatment of adult patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Authorised no no no 2013-11-11
Orion Corporation Stalevo levodopa, carbidopa, entacapone EMEA/H/C/000511
Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.
Authorised no no no 2003-10-17
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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