EPIRUBICIN HYDROCHLORIDE - Generic Drug Details

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

Epirubicin hydrochloride is the generic ingredient in two branded drugs marketed by Pfizer Inc, Actavis Totowa, Cipla Ltd, Ebewe Pharma, Epic Pharma Llc, Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Hospira, Impax Labs Inc, Norvium Bioscience, and Zennova, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for epirubicin hydrochloride. Two suppliers are listed for this compound.

Sponsor	Phase
Jeeyun Lee	Phase 1/Phase 2
Daiichi Sankyo	Phase 3
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 1

Sponsor

Phase

Jeeyun Lee

Phase 1/Phase 2

Daiichi Sankyo

Phase 3

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Phase 1

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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
Fresenius Kabi Usa	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065408-004	Oct 15, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065411-002	Aug 20, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	POWDER;INTRAVENOUS	050807-001	Sep 15, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065343-003	Apr 19, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ebewe Pharma	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065339-002	Dec 22, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065331-002	Aug 9, 2007	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:	0
Tradenames:	2
Applicants:	12
NDAs:	15
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	475
Patent Applications:	7,142
What excipients (inactive ingredients) are in EPIRUBICIN HYDROCHLORIDE?	EPIRUBICIN HYDROCHLORIDE excipients list
DailyMed Link:	EPIRUBICIN HYDROCHLORIDE at DailyMed

Drug Class	Anthracycline Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors