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Last Updated: March 28, 2024

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, 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
Karolinska University HospitalPhase 2
Peng LiuPhase 2
Tianjin Medical University Cancer Institute and HospitalPhase 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 Labs Ltd EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 091599-002 Mar 12, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Impax Labs Inc EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065331-002 Aug 9, 2007 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Institutional EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065371-002 Nov 28, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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