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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Colorcon
Argus Health
Merck
UBS
QuintilesIMS
Citi
McKinsey
Moodys

Generated: April 19, 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: 26
Clinical Trials: 4
Patent Applications: 95
Drug Prices:see details
DailyMed Link:FUSILEV at DailyMed
Drug patent expirations by year for FUSILEV
Medical Subject Heading (MeSH) Categories for FUSILEV
Synonyms for FUSILEV
(S)-5-FORMYL-5,6,7,8-TETRAHYDROFOLIC ACID CALCIUM SALT
1492-18-8
778XL6VBS8
80433-71-2
A839909
AB2000681
AC-24017
AKOS025401656
AN-36399
API0001819
calcium (2S)-2-[[[4-[[(6S)-2-amino-5-formyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl]methylamino]phenyl]-oxomethyl]amino]pentanedioate
calcium (2S)-2-[[4-[[(6S)-2-amino-5-formyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl]methylamino]benzoyl]amino]pentanedioate
calcium (2S)-2-[[4-[[(6S)-2-azanyl-5-methanoyl-4-oxidanylidene-1,6,7,8-tetrahydropteridin-6-yl]methylamino]phenyl]carbonylamino]pentanedioate
calcium (6s)-folinate
calcium folinate
Calcium levofolinate
Calcium levofolinate (Calcium Folinate)
Calcium levofolinate (INN)
Calcium N-(p-((((6S)-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl)amino)benzoyl)-L-glutamate (1:1)
calcium(2+) (2S)-2-{[4-({[(6S)-2-amino-5-formyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl]methyl}amino)phenyl]formamido}pentanedioate
CC0139
CHEMBL1908361
CL 307,782
CL-307782
CS-2466
D04715
D0Q6LA
D0V7RH
DTXSID3045564
Elvorine
Elvorine|||Isovorin|||Calcium (2S)-2-[[4-[[(6S)-2-amino-5-formyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl]methylamino]benzoyl]amino]pentanedioate
Folinic acid l-form calcium salt
Fusilev (TN)
HY-13667
Isovorin
Isovorin (TN)
L-Glutamic acid, N-(4-(((2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl)amino)benzoyl)-, calcium salt (1:1), (S)-
L-Leucovorin calcium
Levofolinate calcium (JAN)
Levoleucovorin (Calcium)
LEVOLEUCOVORIN CALCIUM
Levoleucovorin calcium (USAN)
Levoleucovorin calcium [USAN]
Levoleukovorin calcium
MFCD08704249
MolPort-020-001-403
SCHEMBL467144
SCHEMBL9340225
UNII-778XL6VBS8
UNII-RPR1R4C0P4 component KVUAALJSMIVURS-QNTKWALQSA-L
W-60274

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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Spectrum Pharms FUSILEV levoleucovorin calcium SOLUTION;IV (INFUSION) 020140-002 Apr 29, 2011 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Spectrum Pharms FUSILEV levoleucovorin calcium POWDER;IV (INFUSION) 020140-001 Mar 7, 2008 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Spectrum Pharms FUSILEV levoleucovorin calcium SOLUTION;IV (INFUSION) 020140-002 Apr 29, 2011 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free 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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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 2011-10-26
➤ Subscribe Injection 50 mg/vial ➤ Subscribe 2013-12-19

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 ➤ Try a Free Trial
6,849,628 Optically active compounds ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Cerilliant
Express Scripts
Moodys
Deloitte
AstraZeneca
Julphar
Merck
Queensland Health

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