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Last Updated: June 28, 2022

STALEVO 75 Drug Patent Profile


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When do Stalevo 75 patents expire, and when can generic versions of Stalevo 75 launch?

Stalevo 75 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 75 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Drug patent expirations by year for STALEVO 75
Recent Clinical Trials for STALEVO 75

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

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Asan Medical CenterN/A
IRCCS San RaffaelePhase 2

See all STALEVO 75 clinical trials

US Patents and Regulatory Information for STALEVO 75

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 75

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485-005 Aug 29, 2008 See Plans and Pricing See Plans and Pricing
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485-005 Aug 29, 2008 See Plans and Pricing See Plans and Pricing
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485-005 Aug 29, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for STALEVO 75

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 75

See the table below for patents covering STALEVO 75 around the world.

Country Patent Number Title Estimated Expiration
Poland 154006 See Plans and Pricing
European Patent Office 1189608 PREPARATION PHARMACEUTIQUE A BASE DE LEVODOPA/CARBIDOPA/ENTACAPONE (LEVODOPA/CARBIDOPA/ENTACAPONE PHARMACEUTICAL PREPARATION) See Plans and Pricing
Finland 109453 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STALEVO 75

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0426468 C00426468/01 Switzerland See Plans and Pricing FORMER REPRESENTATIVE: BOHEST AG, CH
0426468 0490007-2 Sweden See Plans and Pricing 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 See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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