LEVOLEUCOVORIN CALCIUM Drug Patent Profile

Which patents cover Levoleucovorin Calcium, and what generic alternatives are available?

Levoleucovorin Calcium is a drug marketed by Actavis Llc, Amneal, Hikma, Meitheal, Ailex Pharms Llc, Gland Pharma Ltd, Hainan Poly Pharm, Mylan Teoranta, Novast Labs, and Sandoz. and is included in thirteen NDAs.

The generic ingredient in LEVOLEUCOVORIN CALCIUM is levoleucovorin calcium. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Levoleucovorin Calcium

A generic version of LEVOLEUCOVORIN CALCIUM was approved as levoleucovorin calcium by SANDOZ on March 9^th, 2015.

Summary for LEVOLEUCOVORIN CALCIUM

US Patents:	0
Applicants:	10
NDAs:	13
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	3
Patent Applications:	249
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVOLEUCOVORIN CALCIUM
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
United States Department of Defense	Phase 2
Phoenix Children's Hospital	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Llc	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	POWDER;INTRAVENOUS	206516-001	Feb 13, 2017		DISCN	No	No
Sandoz	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	203563-001	Mar 9, 2015	AP	RX	No	No
Amneal	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	207548-001	Sep 8, 2017	AP	RX	No	No
Hikma	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	POWDER;INTRAVENOUS	206263-001	Jun 16, 2016		DISCN	No	No
Meitheal	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	211002-001	Aug 16, 2019	AP	RX	No	Yes
Gland Pharma Ltd	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	210892-001	Sep 14, 2018	AP	RX	No	No
Sandoz	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	203563-002	Mar 9, 2015		DISCN	No	No