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Last Updated: March 29, 2020

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STALEVO 200 Drug 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. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-eight patent family members in forty-one countries.

The generic ingredient in STALEVO 200 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

US ANDA Litigation and Generic Entry Outlook for Stalevo 200

Stalevo 200 was eligible for patent challenges on October 19, 2003.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for STALEVO 200
International Patents:58
US Patents:2
Applicants:1
NDAs:1
Bulk Api Vendors: 1
Clinical Trials: 16
Patent Applications: 4
Formulation / Manufacturing:see details
DailyMed Link:STALEVO 200 at DailyMed
Drug patent expirations by year for STALEVO 200
Recent Clinical Trials for STALEVO 200

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

SponsorPhase
Asan Medical CenterN/A
IRCCS San RaffaelePhase 2
SynAgile CorporationPhase 2

See all STALEVO 200 clinical trials

Synonyms for STALEVO 200
745835-09-0
Carbidopa mixture with Entacapone and Levodopa
Carbidopa, levodopa, and entacapone
Carbidopa/levodopa/entacapone
DTXSID10225560
ELC200
L-Tyrosine, 3-hydroxy-, mixt. with (2E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide and (alphaS)-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid
SCHEMBL3808214
Stalevo 100
Stalevo 125
Stalevo 50
Stalevo 75
Paragraph IV (Patent) Challenges for STALEVO 200
Tradename Dosage Ingredient NDA Submissiondate
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
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 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
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 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
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 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
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

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   Start Trial   Start Trial Y   Start Trial
Orion Pharma STALEVO 200 carbidopa; entacapone; levodopa TABLET;ORAL 021485-004 Aug 2, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma STALEVO 200 carbidopa; entacapone; levodopa TABLET;ORAL 021485-004 Aug 2, 2007   Start Trial   Start Trial
Orion Pharma STALEVO 200 carbidopa; entacapone; levodopa TABLET;ORAL 021485-004 Aug 2, 2007   Start Trial   Start Trial
Orion Pharma STALEVO 200 carbidopa; entacapone; levodopa TABLET;ORAL 021485-004 Aug 2, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for STALEVO 200

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0426468 91071 Luxembourg   Start Trial 91071, EXPIRES: 20151101
0426468 0490007-2 Sweden   Start 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
0426468 CA 2004 00007 Denmark   Start Trial
0426468 C00426468/01 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Baxter
Boehringer Ingelheim
Medtronic
Merck

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