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Last Updated: November 27, 2022

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.

Summary for epirubicin hydrochloride
Recent Clinical Trials for epirubicin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Polish Medical Research AgencyPhase 3
Maria Sklodowska-Curie National Research Institute of OncologyPhase 3

See all epirubicin hydrochloride clinical trials

Pharmacology for epirubicin hydrochloride
Medical Subject Heading (MeSH) Categories for epirubicin hydrochloride

US Patents and Regulatory Information for epirubicin hydrochloride

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

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