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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
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Colorcon
Accenture
Boehringer Ingelheim

Generated: May 24, 2019

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FUSILEV Drug Profile

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

Fusilev is a drug marketed by Spectrum Pharms 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. Ten suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

Drug patent expirations by year for FUSILEV
Medical Subject Heading (MeSH) Categories for FUSILEV

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
Spectrum Pharms FUSILEV levoleucovorin calcium POWDER;INTRAVENOUS 020140-001 Mar 7, 2008 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Spectrum Pharms FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-002 Apr 29, 2011 DISCN Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Spectrum Pharms FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-003 Apr 29, 2011 DISCN Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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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Paragraph IV (Patent) Challenges for FUSILEV
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 10 mg/mL, 17.5 mL vial and 25 mL vial ➤ Subscribe ➤ Sign Up
➤ Subscribe Injection 50 mg/vial ➤ Subscribe ➤ Sign Up

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
US Department of Justice
McKesson
Argus Health
Colorcon

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