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Last Updated: April 25, 2024

Levoleucovorin calcium - Generic Drug Details

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What are the generic drug sources for levoleucovorin calcium and what is the scope of freedom to operate?

Levoleucovorin calcium is the generic ingredient in two branded drugs marketed by Acrotech Biopharma, Actavis Llc, Amneal, Hikma, Meitheal, Ailex Pharms Llc, Gland Pharma Ltd, Hainan Poly Pharm, Mylan Teoranta, Novast Labs, and Sandoz, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for levoleucovorin calcium. Ten suppliers are listed for this compound.

Summary for levoleucovorin calcium

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	14
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	3
Patent Applications:	687
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for levoleucovorin calcium
What excipients (inactive ingredients) are in levoleucovorin calcium?	levoleucovorin calcium excipients list
DailyMed Link:	levoleucovorin calcium at DailyMed

Recent Clinical Trials for levoleucovorin calcium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Autism Speaks	Phase 2
New York State Institute for Basic Research	Phase 2
United States Department of Defense	Phase 2

See all levoleucovorin calcium clinical trials

Pharmacology for levoleucovorin calcium

Drug Class	Folate Analog

Medical Subject Heading (MeSH) Categories for levoleucovorin calcium

Antidotes

Paragraph IV (Patent) Challenges for LEVOLEUCOVORIN CALCIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FUSILEV	Injection	levoleucovorin calcium	50 mg/vial	020140	1	2013-12-19
FUSILEV	Injection	levoleucovorin calcium	10 mg/mL, 17.5 mL vial and 25 mL vial	020140	1	2011-10-26

US Patents and Regulatory Information for levoleucovorin calcium

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	203563-002	Mar 9, 2015		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Teoranta	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	203576-002	Oct 20, 2015		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hainan Poly Pharm	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	217314-001	May 22, 2023	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	POWDER;INTRAVENOUS	206263-001	Jun 16, 2016		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for levoleucovorin calcium

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-003	Apr 29, 2011	⤷ Try a Trial	⤷ Try a Trial
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	POWDER;INTRAVENOUS	020140-001	Mar 7, 2008	⤷ Try a Trial	⤷ Try a Trial
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-002	Apr 29, 2011	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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