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
Arcus Biosciences, Inc.	Phase 1/Phase 2
Jonsson Comprehensive Cancer Center	Phase 1/Phase 2

Sponsor

Phase

Fudan University

Phase 3

Arcus Biosciences, Inc.

Phase 1/Phase 2

Jonsson Comprehensive Cancer Center

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
Glaxosmithkline	WELLCOVORIN	leucovorin calcium	INJECTABLE;INJECTION	087439-001	Oct 19, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pharmachemie	LEUCOVORIN CALCIUM	leucovorin calcium	TABLET;ORAL	073101-001	Mar 28, 1997		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ani Pharms	LEUCOVORIN CALCIUM	leucovorin calcium	TABLET;ORAL	075327-001	Mar 24, 1999		DISCN	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
Abraxis Pharm	LEUCOVORIN CALCIUM	leucovorin calcium	INJECTABLE;INJECTION	088939-001	Dec 1, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Pharm	LEUCOVORIN CALCIUM	leucovorin calcium	TABLET;ORAL	071600-001	Oct 14, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novast Labs	LEUCOVORIN CALCIUM	leucovorin calcium	TABLET;ORAL	211132-004	Jul 30, 2020	AB	RX	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

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