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Last Updated: October 18, 2019

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STALEVO 100 Drug Profile

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When do Stalevo 100 patents expire, and when can generic versions of Stalevo 100 launch?

Stalevo 100 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 100 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 100
Recent Clinical Trials for STALEVO 100

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

See all STALEVO 100 clinical trials

Recent Litigation for STALEVO 100

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District Court Litigation
Case NameDate
Orion Corporation v. Mylan Pharmaceuticals Inc.2012-04-26
ORION CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES INC.2007-11-13
Orion Corporation v. Wockhardt USA Inc.2007-09-13

See all STALEVO 100 litigation

Synonyms for STALEVO 100
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 125
Stalevo 200
Stalevo 50
Stalevo 75

US Patents and Regulatory Information for STALEVO 100

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 100 carbidopa; entacapone; levodopa TABLET;ORAL 021485-002 Jun 11, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Orion Pharma STALEVO 100 carbidopa; entacapone; levodopa TABLET;ORAL 021485-002 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 100

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma STALEVO 100 carbidopa; entacapone; levodopa TABLET;ORAL 021485-002 Jun 11, 2003   Start Trial   Start Trial
Orion Pharma STALEVO 100 carbidopa; entacapone; levodopa TABLET;ORAL 021485-002 Jun 11, 2003   Start Trial   Start Trial
Orion Pharma STALEVO 100 carbidopa; entacapone; levodopa TABLET;ORAL 021485-002 Jun 11, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for STALEVO 100
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 25/100/200 mg and 37.5/150/200 mg ➤ Subscribe   Start Trial

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Serving leading biopharmaceutical companies globally:

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