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Last Updated: May 26, 2022

STALEVO 125 Drug Patent Profile


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Which patents cover Stalevo 125, and when can generic versions of Stalevo 125 launch?

Stalevo 125 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 125 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Drug patent expirations by year for STALEVO 125
Recent Clinical Trials for STALEVO 125

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 125 clinical trials

US Patents and Regulatory Information for STALEVO 125

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 125 carbidopa; entacapone; levodopa TABLET;ORAL 021485-006 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 125

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma STALEVO 125 carbidopa; entacapone; levodopa TABLET;ORAL 021485-006 Aug 29, 2008 See Plans and Pricing See Plans and Pricing
Orion Pharma STALEVO 125 carbidopa; entacapone; levodopa TABLET;ORAL 021485-006 Aug 29, 2008 See Plans and Pricing See Plans and Pricing
Orion Pharma STALEVO 125 carbidopa; entacapone; levodopa TABLET;ORAL 021485-006 Aug 29, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for STALEVO 125

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 91071 Luxembourg See Plans and Pricing 91071, EXPIRES: 20151101
0426468 C00426468/01 Switzerland See Plans and Pricing FORMER REPRESENTATIVE: BOHEST AG, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
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Harvard Business School
Baxter

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