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Last Updated: March 19, 2024

IDARUBICIN HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for idarubicin hydrochloride and what is the scope of patent protection?

Idarubicin hydrochloride is the generic ingredient in three branded drugs marketed by Pfizer, Fresenius Kabi Usa, Hikma, Meitheal, Mylan Labs Ltd, Sandoz, and Teva Parenteral, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for idarubicin hydrochloride. Two suppliers are listed for this compound.

Summary for IDARUBICIN HYDROCHLORIDE
Recent Clinical Trials for IDARUBICIN HYDROCHLORIDE

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

SponsorPhase
Ho Joon ImPhase 2
Shanghai General Hospital, Shanghai Jiao Tong University School of MedicinePhase 2
Zhongda HospitalPhase 2/Phase 3

See all IDARUBICIN HYDROCHLORIDE clinical trials

Pharmacology for IDARUBICIN HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for IDARUBICIN HYDROCHLORIDE

US Patents and Regulatory Information for IDARUBICIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz IDARUBICIN HYDROCHLORIDE idarubicin hydrochloride INJECTABLE;INJECTION 091293-001 Mar 29, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd IDARUBICIN HYDROCHLORIDE idarubicin hydrochloride INJECTABLE;INJECTION 200144-001 Oct 11, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal IDARUBICIN HYDROCHLORIDE idarubicin hydrochloride INJECTABLE;INJECTION 065036-001 May 1, 2002 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Parenteral IDARUBICIN HYDROCHLORIDE idarubicin hydrochloride INJECTABLE;INJECTION 065037-003 May 1, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer IDAMYCIN idarubicin hydrochloride INJECTABLE;INJECTION 050661-001 Sep 27, 1990 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Parenteral IDARUBICIN HYDROCHLORIDE idarubicin hydrochloride INJECTABLE;INJECTION 065037-002 May 1, 2002 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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