CEFEPIME HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for cefepime hydrochloride and what is the scope of freedom to operate?

Cefepime hydrochloride is the generic ingredient in six branded drugs marketed by B Braun, Acs Dobfar, Astral, Fosun Pharma, Hospira Inc, Qilu, Sagent Pharms Inc, Baxter Hlthcare, Samson Medcl, and Allecra Theraps, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for cefepime hydrochloride. Ten suppliers are listed for this compound.

Sponsor

Phase

Meiji Seika Pharma Co., Ltd.

Phase 3

Allecra

Phase 2

Linical Co., Ltd.

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
Hospira Inc	CEFEPIME HYDROCHLORIDE	cefepime hydrochloride	INJECTABLE;INJECTION	202268-001	Jul 30, 2012		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira Inc	MAXIPIME	cefepime hydrochloride	INJECTABLE;INJECTION	050679-003	Jan 18, 1996		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira Inc	MAXIPIME	cefepime hydrochloride	INJECTABLE;INJECTION	050679-002	Jan 18, 1996		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira Inc	MAXIPIME	cefepime hydrochloride	INJECTABLE;INJECTION	050679-001	Jan 18, 1996		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allecra Theraps	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		RX	Yes	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:	6
Applicants:	10
NDAs:	12
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	60
Patent Applications:	900
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in CEFEPIME HYDROCHLORIDE?	CEFEPIME HYDROCHLORIDE excipients list
DailyMed Link:	CEFEPIME HYDROCHLORIDE at DailyMed