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Last Updated: January 18, 2020

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STALEVO 150 Drug Profile

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When do Stalevo 150 patents expire, and when can generic versions of Stalevo 150 launch?

Stalevo 150 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 150 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 150

  Start Trial

Stalevo 150 was eligible for patent challenges on October 19th, 2003.

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

Summary for STALEVO 150
International Patents:58
US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: 4
Clinical Trials: 16
Formulation / Manufacturing:see details
DailyMed Link:STALEVO 150 at DailyMed
Drug patent expirations by year for STALEVO 150
Recent Clinical Trials for STALEVO 150

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

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

See all STALEVO 150 clinical trials

Paragraph IV (Patent) Challenges for STALEVO 150
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 150

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 150 carbidopa; entacapone; levodopa TABLET;ORAL 021485-003 Jun 11, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Orion Pharma STALEVO 150 carbidopa; entacapone; levodopa TABLET;ORAL 021485-003 Jun 11, 2003 AB 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 150

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma STALEVO 150 carbidopa; entacapone; levodopa TABLET;ORAL 021485-003 Jun 11, 2003   Start Trial   Start Trial
Orion Pharma STALEVO 150 carbidopa; entacapone; levodopa TABLET;ORAL 021485-003 Jun 11, 2003   Start Trial   Start Trial
Orion Pharma STALEVO 150 carbidopa; entacapone; levodopa TABLET;ORAL 021485-003 Jun 11, 2003   Start Trial   Start Trial
Orion Pharma STALEVO 150 carbidopa; entacapone; levodopa TABLET;ORAL 021485-003 Jun 11, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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