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Generated: October 19, 2018

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FUSILEV Drug Profile

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Which patents cover Fusilev, and what generic alternatives are available?

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.

The generic ingredient in FUSILEV is levoleucovorin calcium. There is one drug master file entry for this compound. Nine 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
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;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 ➤ Sign Up
Spectrum Pharms FUSILEV levoleucovorin calcium POWDER;INTRAVENOUS 020140-001 Mar 7, 2008 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ 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 ➤ 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
Dow
Accenture
Moodys
McKesson
Deloitte
US Army
Farmers Insurance
Medtronic

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