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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

Medical Subject Heading (MeSH) Categories for FUSILEV

Antidotes

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			Y	Y
Spectrum Pharms	FUSILEV	levoleucovorin calcium	SOLUTION;IV (INFUSION)	020140-002	Apr 29, 2011		DISCN	Yes	No
Spectrum Pharms	FUSILEV	levoleucovorin calcium	POWDER;IV (INFUSION)	020140-001	Mar 7, 2008	AP	RX	Yes	Yes
Spectrum Pharms	FUSILEV	levoleucovorin calcium	SOLUTION;IV (INFUSION)	020140-002	Apr 29, 2011		DISCN	Yes	No			Y	Y

Paragraph IV (Patent) Challenges for FUSILEV

Drugname	Dosage	Strength	RLD	Submissiondate
	Injection	10 mg/mL, 17.5 mL vial and 25 mL vial		2011-10-26
	Injection	50 mg/vial		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
6,849,628	Optically active compounds

International Patents for FUSILEV

Country	Document Number	Estimated Expiration
Germany	3752362
Japan	2844532
European Patent Office	0266042
Spain	2191669