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, Hainan Poly, Hikma, Meitheal, Pharmachemie, Pharmachemie Usa, Teva Parenteral, Teva Pharms Usa, Am Regent, Fresenius Kabi Usa, Mylan Labs Ltd, Sagent Pharms, Sagent Pharms Inc, Glaxosmithkline, Novast Labs, 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
Hikma	LEUCOVORIN CALCIUM	leucovorin calcium	INJECTABLE;INJECTION	089384-001	Sep 14, 1987	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmachemie	LEUCOVORIN CALCIUM	leucovorin calcium	TABLET;ORAL	073101-001	Mar 28, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	LEUCOVORIN CALCIUM	leucovorin calcium	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	207241-001	Mar 14, 2018		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abic	LEUCOVORIN CALCIUM	leucovorin calcium	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	089352-001	Jun 1, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	LEUCOVORIN CALCIUM	leucovorin calcium	TABLET;ORAL	075327-001	Mar 24, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hainan Poly	LEUCOVORIN CALCIUM	leucovorin calcium	INJECTABLE;INJECTION	217021-004	Jul 10, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	LEUCOVORIN CALCIUM PRESERVATIVE FREE	leucovorin calcium	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	040347-002	Apr 25, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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:	477
Patent Applications:	7,027
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