Cefepime hydrochloride - Generic Drug Details

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What are the generic drug 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, Chartwell Rx, Hikma, Hospira Inc, Qilu, Sagent Pharms Inc, Baxter Hlthcare, Samson Medcl, and Allecra Theraps, and is included in thirteen 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. Nine suppliers are listed for this compound.

Sponsor	Phase
Biomedical Advanced Research and Development Authority	Phase 3
Meiji Seika Pharma Co., Ltd.	Phase 3
Linical Co., Ltd.	Phase 2

Sponsor

Phase

Biomedical Advanced Research and Development Authority

Phase 3

Meiji Seika Pharma Co., Ltd.

Phase 3

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
Hikma	CEFEPIME HYDROCHLORIDE	cefepime hydrochloride	INJECTABLE;INJECTION	214402-002	May 22, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Allecra Theraps	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Allecra Theraps	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Samson Medcl	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	cefepime hydrochloride	POWDER;INTRAVENOUS	209408-001	Aug 21, 2018		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Qilu	CEFEPIME HYDROCHLORIDE	cefepime hydrochloride	INJECTABLE;INJECTION	203704-002	Feb 1, 2016	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Qilu	CEFEPIME HYDROCHLORIDE	cefepime hydrochloride	INJECTABLE;INJECTION	203704-003	Feb 1, 2016	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acs Dobfar	CEFEPIME HYDROCHLORIDE	cefepime hydrochloride	INJECTABLE;INJECTION	065441-002	Mar 20, 2008	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:	11
NDAs:	13
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	61
Patent Applications:	761
What excipients (inactive ingredients) are in cefepime hydrochloride?	cefepime hydrochloride excipients list
DailyMed Link:	cefepime hydrochloride at DailyMed