CEFUROXIME SODIUM - Generic Drug Details

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What are the generic drug sources for cefuroxime sodium and what is the scope of patent protection?

Cefuroxime sodium is the generic ingredient in seven branded drugs marketed by B Braun, Acs Dobfar Spa, Fresenius Kabi Usa, Hikma, Hospira Inc, Teva Pharms, Watson Labs Inc, Samson Medcl, Acs Dobfar, Lilly, and Pai Holdings Pharm, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for cefuroxime sodium. Three suppliers are listed for this compound.

Sponsor	Phase
Hospital Universitari Vall d'Hebron Research Institute	Phase 4
University Hospital, Basel, Switzerland	Phase 4
PriCara, Unit of Ortho-McNeil, Inc.	Phase 2/Phase 3

Sponsor

Phase

Hospital Universitari Vall d'Hebron Research Institute

Phase 4

University Hospital, Basel, Switzerland

Phase 4

PriCara, Unit of Ortho-McNeil, Inc.

Phase 2/Phase 3

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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
Watson Labs Inc	CEFUROXIME SODIUM	cefuroxime sodium	INJECTABLE;INJECTION	064035-002	Feb 26, 1993		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lilly	KEFUROX IN PLASTIC CONTAINER	cefuroxime sodium	INJECTABLE;INTRAVENOUS	062590-001	Jan 10, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	CEFUROXIME SODIUM	cefuroxime sodium	INJECTABLE;INJECTION	065046-001	Jan 9, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pai Holdings Pharm	ZINACEF IN PLASTIC CONTAINER	cefuroxime sodium	INJECTABLE;INJECTION	050643-002	Apr 28, 1989		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acs Dobfar	KEFUROX	cefuroxime sodium	INJECTABLE;INJECTION	062591-002	Jan 10, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acs Dobfar Spa	CEFUROXIME SODIUM	cefuroxime sodium	INJECTABLE;INJECTION	064125-002	May 30, 1997	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acs Dobfar	KEFUROX	cefuroxime sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	062591-001	Jan 10, 1986		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:	7
Applicants:	11
NDAs:	20
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	3
Patent Applications:	1,382
What excipients (inactive ingredients) are in CEFUROXIME SODIUM?	CEFUROXIME SODIUM excipients list
DailyMed Link:	CEFUROXIME SODIUM at DailyMed