Idarubicin hydrochloride - Generic Drug Details

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What are the generic drug sources for idarubicin hydrochloride and what is the scope of freedom to operate?

Idarubicin hydrochloride is the generic ingredient in three branded drugs marketed by Pfizer, Fresenius Kabi Usa, Hikma, Meitheal, Rising, 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.

Sponsor	Phase
Kura Oncology, Inc.	Phase 1
Acute Leukemia French Association	Phase 2
Fred Hutchinson Cancer Center	Phase 1

Sponsor

Phase

Kura Oncology, Inc.

Phase 1

Acute Leukemia French Association

Phase 2

Fred Hutchinson Cancer Center

Phase 1

US Patents and Regulatory Information for idarubicin hydrochloride

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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
Rising	IDARUBICIN HYDROCHLORIDE	idarubicin hydrochloride	INJECTABLE;INJECTION	200144-001	Oct 11, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Parenteral	IDARUBICIN HYDROCHLORIDE	idarubicin hydrochloride	INJECTABLE;INJECTION	065037-003	May 1, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Parenteral	IDARUBICIN HYDROCHLORIDE	idarubicin hydrochloride	INJECTABLE;INJECTION	065037-001	May 1, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meitheal	IDARUBICIN HYDROCHLORIDE	idarubicin hydrochloride	INJECTABLE;INJECTION	065036-001	May 1, 2002	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	IDAMYCIN	idarubicin hydrochloride	INJECTABLE;INJECTION	050661-001	Sep 27, 1990		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	IDARUBICIN HYDROCHLORIDE	idarubicin hydrochloride	INJECTABLE;INJECTION	065275-001	Dec 14, 2006	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	IDARUBICIN HYDROCHLORIDE	idarubicin hydrochloride	INJECTABLE;INJECTION	065288-001	May 15, 2007	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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:	3
Applicants:	7
NDAs:	9
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	273
Patent Applications:	7,453
What excipients (inactive ingredients) are in idarubicin hydrochloride?	idarubicin hydrochloride excipients list
DailyMed Link:	idarubicin hydrochloride at DailyMed

Drug Class	Anthracycline Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Idarubicin hydrochloride - Generic Drug Details

What are the generic drug sources for idarubicin hydrochloride and what is the scope of freedom to operate?

Summary for idarubicin hydrochloride

Recent Clinical Trials for idarubicin hydrochloride

Pharmacology for idarubicin hydrochloride

Medical Subject Heading (MeSH) Categories for idarubicin hydrochloride

Anatomical Therapeutic Chemical (ATC) Classes for idarubicin hydrochloride

US Patents and Regulatory Information for idarubicin hydrochloride

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