LEUCOVORIN CALCIUM - Generic Drug Details

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

Leucovorin calcium is the generic ingredient in three branded drugs marketed by Hospira, Abic, Abraxis Pharm, Elkins Sinn, Fresenius Kabi Usa, Hainan Poly, Hikma, Kindos, Novast Labs, Pharmachemie, Pharmachemie Usa, Teva Parenteral, Teva Pharms Usa, Am Regent, Mylan Labs Ltd, Sagent Pharms, Sagent Pharms Inc, Glaxosmithkline, Ani Pharms, Barr, Epic Pharma Llc, Leading, Par Pharm, and Xanodyne Pharm, and is included in fifty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for leucovorin calcium. Fourteen suppliers are listed for this compound.

Sponsor	Phase
Fudan University	Phase 3
Jonsson Comprehensive Cancer Center	Phase 1/Phase 2
Arcus Biosciences, Inc.	Phase 1/Phase 2

Sponsor

Phase

Fudan University

Phase 3

Jonsson Comprehensive Cancer Center

Phase 1/Phase 2

Arcus Biosciences, Inc.

Phase 1/Phase 2

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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
Teva Parenteral	LEUCOVORIN CALCIUM PRESERVATIVE FREE	leucovorin calcium	INJECTABLE;INJECTION	040332-001	Jun 28, 1999		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Am Regent	LEUCOVORIN CALCIUM PRESERVATIVE FREE	leucovorin calcium	INJECTABLE;INJECTION	040338-001	Jan 31, 2001		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sagent Pharms	LEUCOVORIN CALCIUM PRESERVATIVE FREE	leucovorin calcium	INJECTABLE;INJECTION	200753-003	Sep 6, 2012	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abic	LEUCOVORIN CALCIUM	leucovorin calcium	INJECTABLE;INJECTION	089353-001	Jun 1, 1988		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Leading	LEUCOVORIN CALCIUM	leucovorin calcium	TABLET;ORAL	213929-003	Oct 22, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	LEUCOVORIN CALCIUM PRESERVATIVE FREE	leucovorin calcium	INJECTABLE;INJECTION	040335-001	Apr 20, 2000	AP	RX	No	Yes	⤷ 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

US Patents:	0
Tradenames:	3
Applicants:	24
NDAs:	53
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	476
Patent Applications:	6,867
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for LEUCOVORIN CALCIUM
What excipients (inactive ingredients) are in LEUCOVORIN CALCIUM?	LEUCOVORIN CALCIUM excipients list
DailyMed Link:	LEUCOVORIN CALCIUM at DailyMed