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Last Updated: May 24, 2024

STALEVO 50 Drug Patent Profile


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When do Stalevo 50 patents expire, and what generic alternatives are available?

Stalevo 50 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 50 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Drug patent expirations by year for STALEVO 50
Recent Clinical Trials for STALEVO 50

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

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Asan Medical CenterN/A
SynAgile CorporationPhase 2

See all STALEVO 50 clinical trials

US Patents and Regulatory Information for STALEVO 50

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 50 carbidopa; entacapone; levodopa TABLET;ORAL 021485-001 Jun 11, 2003 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 STALEVO 50

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

EU/EMA Drug Approvals for STALEVO 50

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

Supplementary Protection Certificates for STALEVO 50

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0426468 C00426468/01 Switzerland ⤷  Sign Up FORMER REPRESENTATIVE: BOHEST AG, CH
0426468 91071 Luxembourg ⤷  Sign Up 91071, EXPIRES: 20151101
0426468 0490007-2 Sweden ⤷  Sign Up PRODUCT NAME: (E)-2-CYANO-N,N-DIETYL-3-(3,4-DIHYDROXI-5-NITROFENYL)AKRYLAMID; REGSISTRATION NO/DATE: EU/1/03/260/001 20031017
0426468 CA 2004 00007 Denmark ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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