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Serving 500+ biopharmaceutical companies globally:

Moodys
US Department of Justice
US Army
Fish and Richardson
Farmers Insurance
Medtronic
Julphar
McKinsey
Accenture
Healthtrust

Generated: August 22, 2017

DrugPatentWatch Database Preview

FUSILEV Drug Profile

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What is the patent landscape for Fusilev, 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. Six 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
Bulk Api Vendors: see list8
Clinical Trials: see list2
Patent Applications: see list2,257
Drug Prices:see details
DailyMed Link:FUSILEV at DailyMed
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;IV (INFUSION)020140-001Mar 7, 2008APRXYesYes► Subscribe► SubscribeYY ► Subscribe
Spectrum Pharms
FUSILEV
levoleucovorin calcium
SOLUTION;IV (INFUSION)020140-002Apr 29, 2011DISCNYesNo► Subscribe► Subscribe► Subscribe
Spectrum Pharms
FUSILEV
levoleucovorin calcium
POWDER;IV (INFUSION)020140-001Mar 7, 2008APRXYesYes► Subscribe► Subscribe► Subscribe
Spectrum Pharms
FUSILEV
levoleucovorin calcium
SOLUTION;IV (INFUSION)020140-002Apr 29, 2011DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Spectrum Pharms
FUSILEV
levoleucovorin calcium
SOLUTION;IV (INFUSION)020140-003Apr 29, 2011DISCNYesNo► Subscribe► 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
Austria231150► Subscribe
JapanH11106342► Subscribe
Germany3752362► Subscribe
Australia598024► Subscribe
Japan2844532► 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.

Export unavailable in trial.
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Serving 500+ biopharmaceutical companies globally:

Dow
Chubb
Julphar
AstraZeneca
Citi
Cipla
Deloitte
McKesson
Teva
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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