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Last Updated: February 27, 2021

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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 Inc, Cipla Ltd, Ebewe Pharma, Fresenius Kabi Usa, Hisun Pharm Hangzhou, Hospira, Impax Labs Inc, Mylan Institutional, Mylan Labs Ltd, West-ward Pharms Int, 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. Four suppliers are listed for this compound.

Recent Clinical Trials for epirubicin hydrochloride

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

SponsorPhase
The First Affiliated Hospital with Nanjing Medical UniversityPhase 2
Providence Health & ServicesPhase 1
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 2/Phase 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
Fresenius Kabi Usa EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065411-002 Aug 20, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065408-003 Oct 15, 2007 RX No No   Start Trial   Start Trial   Start Trial
Hospira EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065343-003 Apr 19, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065331-002 Aug 9, 2007 AP RX No No   Start Trial   Start Trial   Start Trial
>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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