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Last Updated: July 8, 2020

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STALEVO 50 Drug Profile


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When do Stalevo 50 patents expire, and what generic alternatives are available?

Stalevo 50 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 50 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.

US ANDA Litigation and Generic Entry Outlook for Stalevo 50

Stalevo 50 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 50
Drug patent expirations by year for STALEVO 50
Recent Clinical Trials for STALEVO 50

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

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

See all STALEVO 50 clinical trials

Paragraph IV (Patent) Challenges for STALEVO 50
Tradename Dosage Ingredient NDA Submissiondate
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 100 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 50

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 50 carbidopa; entacapone; levodopa TABLET;ORAL 021485-001 Jun 11, 2003 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Orion Pharma STALEVO 50 carbidopa; entacapone; levodopa TABLET;ORAL 021485-001 Jun 11, 2003 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 50

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma STALEVO 50 carbidopa; entacapone; levodopa TABLET;ORAL 021485-001 Jun 11, 2003   Start Trial   Start Trial
Orion Pharma STALEVO 50 carbidopa; entacapone; levodopa TABLET;ORAL 021485-001 Jun 11, 2003   Start Trial   Start Trial
Orion Pharma STALEVO 50 carbidopa; entacapone; levodopa TABLET;ORAL 021485-001 Jun 11, 2003   Start Trial   Start Trial
Orion Pharma STALEVO 50 carbidopa; entacapone; levodopa TABLET;ORAL 021485-001 Jun 11, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for STALEVO 50

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0426468 CA 2004 00007 Denmark   Start Trial
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 C00426468/01 Switzerland   Start Trial 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:

McKesson
Merck
Colorcon
AstraZeneca
Baxter
Mallinckrodt

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