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FUSILEV Drug Profile

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Fusilev is a drug marketed by Spectrum Pharms and is included in one NDA. It is available from one supplier. 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. Five suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

Summary for Tradename: FUSILEV

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Spectrum Pharms
FUSILEV
levoleucovorin calcium
POWDER;IV (INFUSION)020140-001Mar 7, 2008RXYes6,500,829► subscribeYY ► subscribe
Spectrum Pharms
FUSILEV
levoleucovorin calcium
SOLUTION;IV (INFUSION)020140-002Apr 29, 2011DISCNNo► subscribe► subscribe
Spectrum Pharms
FUSILEV
levoleucovorin calcium
POWDER;IV (INFUSION)020140-001Mar 7, 2008RXYes► subscribe► subscribe
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Paragraph IV activity for: FUSILEV

Drugname Dosage Strength RLD Submissiondate
levoleucovorin calciumInjection10 mg/mL, 17.5 mL vial and 25 mL vialFusilev10/26/2011
levoleucovorin calciumInjection50 mg/vialFusilev12/19/2013

Non-Orange Book Patents for Tradename: FUSILEV

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
4,959,472 Process for preparing substantially pure diastereoisomers of tetrahydrofolic derivatives► subscribe
6,849,628 Optically active compounds► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: FUSILEV

Country Document Number Estimated Expiration
South Africa8706562► subscribe
Canada1339368► subscribe
Austria230746► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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