Levoleucovorin - Generic Drug Details

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

Levoleucovorin is the generic ingredient in three 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 fifteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for levoleucovorin. One supplier is listed for this compound.

Summary for levoleucovorin

US Patents:	1
Tradenames:	3
Applicants:	11
NDAs:	15
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	14
Patent Applications:	3,154
Drug Prices:	Drug price trends for levoleucovorin
What excipients (inactive ingredients) are in levoleucovorin?	levoleucovorin excipients list
DailyMed Link:	levoleucovorin at DailyMed

See drug prices for levoleucovorin

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for levoleucovorin

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for levoleucovorin

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

Sponsor	Phase
Seagen Inc.	Phase 3
Eisai Inc.	Phase 3
Merck Sharp & Dohme Corp.	Phase 3

See all levoleucovorin clinical trials

Pharmacology for levoleucovorin

Drug Class

Folate Analog

US Patents and Regulatory Information for levoleucovorin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ailex Pharms Llc	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	213797-001	Nov 2, 2021		DISCN	No	No
Sandoz	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	203563-001	Mar 9, 2015	AP	RX	No	No
Novast Labs	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	210623-002	May 3, 2018		DISCN	No	No
Sandoz	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	203563-002	Mar 9, 2015		DISCN	No	No
Actavis Llc	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	POWDER;INTRAVENOUS	208723-001	Sep 29, 2016		DISCN	Yes	No
Amneal	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	207548-001	Sep 8, 2017	AP	RX	No	No