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Last Updated: January 28, 2022

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STALEVO 200 Drug Patent Profile


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When do Stalevo 200 patents expire, and when can generic versions of Stalevo 200 launch?

Stalevo 200 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 200 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 200
Recent Clinical Trials for STALEVO 200

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 200 clinical trials

Paragraph IV (Patent) Challenges for STALEVO 200
Tradename Dosage Ingredient NDA Submissiondate
STALEVO 150 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 150 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 150 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 150 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29

US Patents and Regulatory Information for STALEVO 200

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 200 carbidopa; entacapone; levodopa TABLET;ORAL 021485-004 Aug 2, 2007 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free 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 STALEVO 200

Supplementary Protection Certificates for STALEVO 200

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

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Baxter
Boehringer Ingelheim
Medtronic
Merck

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