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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Baxter
Harvard Business School
US Army
QuintilesIMS
McKinsey
Chubb
Medtronic
Moodys
Fish and Richardson

Generated: January 18, 2018

DrugPatentWatch Database Preview

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. Six suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
Summary for FUSILEV
International Patents:21
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 58
Clinical Trials: 4
Patent Applications: 93
Drug Prices:see details
DailyMed Link:FUSILEV at DailyMed
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;IV (INFUSION) 020140-001 Mar 7, 2008 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Spectrum Pharms FUSILEV levoleucovorin calcium SOLUTION;IV (INFUSION) 020140-002 Apr 29, 2011 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Spectrum Pharms FUSILEV levoleucovorin calcium POWDER;IV (INFUSION) 020140-001 Mar 7, 2008 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Spectrum Pharms FUSILEV levoleucovorin calcium SOLUTION;IV (INFUSION) 020140-002 Apr 29, 2011 DISCN Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Spectrum Pharms FUSILEV levoleucovorin calcium SOLUTION;IV (INFUSION) 020140-003 Apr 29, 2011 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Spectrum Pharms FUSILEV levoleucovorin calcium SOLUTION;IV (INFUSION) 020140-003 Apr 29, 2011 DISCN Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
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 Submissiondate
➤ Subscribe Injection 10 mg/mL, 17.5 mL vial and 25 mL vial ➤ Subscribe 10/26/2011
➤ Subscribe Injection 50 mg/vial ➤ Subscribe 12/19/2013

Non-Orange Book US Patents for 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
Patent No. Title Estimated Patent Expiration

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International Patents for FUSILEV

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Serving leading biopharmaceutical companies globally:

Fuji
Federal Trade Commission
Novartis
Chinese Patent Office
Citi
Queensland Health
Cerilliant
Merck
McKesson

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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