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, Akorn, Cipla Ltd, Ebewe Pharma, Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Hospira, Impax Labs Inc, Mylan Institutional, Mylan Labs Ltd, 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
First Affiliated Hospital Xi'an Jiaotong University	N/A
Polish Medical Research Agency	Phase 3
Maria Sklodowska-Curie National Research Institute of Oncology	Phase 3

Sponsor

Phase

First Affiliated Hospital Xi'an Jiaotong University

N/A

Polish Medical Research Agency

Phase 3

Maria Sklodowska-Curie National Research Institute of Oncology

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
Mylan Institutional	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065371-001	Nov 28, 2007		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Cipla Ltd	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065361-001	Oct 22, 2007	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Ebewe Pharma	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065339-001	Dec 22, 2009		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Fresenius Kabi Usa	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065411-002	Aug 20, 2007		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Hikma	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065289-002	Jun 27, 2007	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Actavis Totowa	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065445-003	Sep 18, 2008	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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:	13
NDAs:	15
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	457
Patent Applications:	7,245
Formulation / Manufacturing:	see details
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