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Last Updated: May 27, 2024

STALEVO 100 Drug Patent Profile


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Which patents cover Stalevo 100, and when can generic versions of Stalevo 100 launch?

Stalevo 100 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 100 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 100
Recent Clinical Trials for STALEVO 100

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 100 clinical trials

US Patents and Regulatory Information for STALEVO 100

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 100 carbidopa; entacapone; levodopa TABLET;ORAL 021485-002 Jun 11, 2003 AB RX Yes No ⤷  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 100

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma STALEVO 100 carbidopa; entacapone; levodopa TABLET;ORAL 021485-002 Jun 11, 2003 ⤷  Sign Up ⤷  Sign Up
Orion Pharma STALEVO 100 carbidopa; entacapone; levodopa TABLET;ORAL 021485-002 Jun 11, 2003 ⤷  Sign Up ⤷  Sign Up
Orion Pharma STALEVO 100 carbidopa; entacapone; levodopa TABLET;ORAL 021485-002 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 100

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

International Patents for STALEVO 100

See the table below for patents covering STALEVO 100 around the world.

Country Patent Number Title Estimated Expiration
Portugal 86236 PROCESSO PARA A PREPARACAO DE DERIVADOS DE CATECOL E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM ⤷  Sign Up
Germany 122004000014 ⤷  Sign Up
United Kingdom 8924838 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STALEVO 100

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0426468 CA 2004 00007 Denmark ⤷  Sign Up
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 C00426468/01 Switzerland ⤷  Sign Up FORMER REPRESENTATIVE: BOHEST AG, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.