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. There are two patents protecting this compound. 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
B Braun	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	cefepime hydrochloride	INJECTABLE;INJECTION	050821-002	May 6, 2010		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira Inc	CEFEPIME HYDROCHLORIDE	cefepime hydrochloride	INJECTABLE;INJECTION	202268-001	Jul 30, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sagent Pharms Inc	CEFEPIME HYDROCHLORIDE	cefepime hydrochloride	INJECTABLE;INJECTION	091048-001	Jan 4, 2017	AP	RX	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:	2
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:	761
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in CEFEPIME HYDROCHLORIDE?	CEFEPIME HYDROCHLORIDE excipients list
DailyMed Link:	CEFEPIME HYDROCHLORIDE at DailyMed