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Last Updated: February 26, 2020

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STALEVO 125 Drug Profile


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When do Stalevo 125 patents expire, and what generic alternatives are available?

Stalevo 125 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 125 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.

US ANDA Litigation and Generic Entry Outlook for Stalevo 125

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

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

See all STALEVO 125 clinical trials

Synonyms for STALEVO 125
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 200
Stalevo 50
Stalevo 75
Paragraph IV (Patent) Challenges for STALEVO 125
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 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 200 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 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 RX Yes No   Start Trial   Start Trial Y   Start Trial
Orion Pharma STALEVO 125 carbidopa; entacapone; levodopa TABLET;ORAL 021485-006 Aug 29, 2008 RX Yes No   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 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   Start Trial   Start Trial
Orion Pharma STALEVO 125 carbidopa; entacapone; levodopa TABLET;ORAL 021485-006 Aug 29, 2008   Start Trial   Start Trial
Orion Pharma STALEVO 125 carbidopa; entacapone; levodopa TABLET;ORAL 021485-006 Aug 29, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Harvard Business School
AstraZeneca
Medtronic
Johnson and Johnson
Dow

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