Daunorubicin hydrochloride - Generic Drug Details

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

Daunorubicin hydrochloride is the generic ingredient in two branded drugs marketed by Hikma, Sanofi Aventis Us, Wyeth Ayerst, Fresenius Kabi Usa, Hisun Pharm Hangzhou, Meitheal, and Teva Parenteral, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for daunorubicin hydrochloride. Two suppliers are listed for this compound.

Sponsor	Phase
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	Phase 3
Gilead Sciences	Phase 2
Uwe Platzbecker	Phase 2

Sponsor

Phase

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Phase 3

Gilead Sciences

Phase 2

Uwe Platzbecker

Phase 2

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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
Teva Parenteral	DAUNORUBICIN HYDROCHLORIDE	daunorubicin hydrochloride	INJECTABLE;INJECTION	064212-002	May 3, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	DAUNORUBICIN HYDROCHLORIDE	daunorubicin hydrochloride	INJECTABLE;INJECTION	065034-001	Nov 20, 2001		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meitheal	DAUNORUBICIN HYDROCHLORIDE	daunorubicin hydrochloride	INJECTABLE;INJECTION	065035-001	Jan 24, 2000	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	DAUNORUBICIN HYDROCHLORIDE	daunorubicin hydrochloride	INJECTABLE;INJECTION	050731-001	Jan 30, 1998	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	CERUBIDINE	daunorubicin hydrochloride	INJECTABLE;INJECTION	061876-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Parenteral	DAUNORUBICIN HYDROCHLORIDE	daunorubicin hydrochloride	INJECTABLE;INJECTION	064212-001	Jun 23, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wyeth Ayerst	CERUBIDINE	daunorubicin hydrochloride	INJECTABLE;INJECTION	050484-001	Approved Prior to Jan 1, 1982		DISCN	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:	2
Applicants:	7
NDAs:	10
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	374
Patent Applications:	7,414
What excipients (inactive ingredients) are in daunorubicin hydrochloride?	daunorubicin hydrochloride excipients list
DailyMed Link:	daunorubicin hydrochloride at DailyMed

Drug Class	Anthracycline Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors