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Last Updated: August 12, 2020

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FUSILEV Drug Profile

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Which patents cover Fusilev, and what generic alternatives are available?

Fusilev is a drug marketed by Acrotech and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-one patent family members in nine countries.

The generic ingredient in FUSILEV is levoleucovorin calcium. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

Drug patent expirations by year for FUSILEV
Drug Prices for FUSILEV

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Recent Clinical Trials for FUSILEV

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SponsorPhase
National Cancer Institute (NCI)Phase 1/Phase 2
Academic and Community Cancer Research UnitedPhase 1/Phase 2
AmgenPhase 3

See all FUSILEV clinical trials

Paragraph IV (Patent) Challenges for FUSILEV
Tradename Dosage Ingredient NDA Submissiondate
FUSILEV SOLUTION;INTRAVENOUS levoleucovorin calcium 020140 2013-12-19
FUSILEV POWDER;INTRAVENOUS levoleucovorin calcium 020140 2013-12-19
FUSILEV POWDER;INTRAVENOUS levoleucovorin calcium 020140 2011-10-26
FUSILEV SOLUTION;INTRAVENOUS levoleucovorin calcium 020140 2011-10-26

US Patents and Regulatory Information for FUSILEV

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acrotech FUSILEV levoleucovorin calcium POWDER;INTRAVENOUS 020140-001 Mar 7, 2008 AP RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Acrotech FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-002 Apr 29, 2011 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Acrotech FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-003 Apr 29, 2011 DISCN Yes No   Start Trial   Start Trial Y 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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Merck
Moodys
Boehringer Ingelheim
Johnson and Johnson

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