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Last Updated: October 20, 2019

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STALEVO 75 Drug Profile

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When do Stalevo 75 patents expire, and what generic alternatives are available?

Stalevo 75 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 75 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.

Summary for STALEVO 75
Drug patent expirations by year for STALEVO 75
Recent Clinical Trials for STALEVO 75

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

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

See all STALEVO 75 clinical trials

Synonyms for STALEVO 75
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 200
Stalevo 50

US Patents and Regulatory Information for STALEVO 75

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 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485-005 Aug 29, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485-005 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 75

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485-005 Aug 29, 2008   Start Trial   Start Trial
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485-005 Aug 29, 2008   Start Trial   Start Trial
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485-005 Aug 29, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for STALEVO 75
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 18.75 mg/75 mg/200 mg and 31.25 mg/125 mg/200 mg ➤ Subscribe   Start Trial

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