Mitoxantrone hydrochloride - Generic Drug Details

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

Mitoxantrone hydrochloride is the generic ingredient in two branded drugs marketed by Fresenius Kabi Oncol, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, Rising, and Emd Serono, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for mitoxantrone hydrochloride. Two suppliers are listed for this compound.

Summary for mitoxantrone hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	8
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	380
Patent Applications:	7,311
What excipients (inactive ingredients) are in mitoxantrone hydrochloride?	mitoxantrone hydrochloride excipients list
DailyMed Link:	mitoxantrone hydrochloride at DailyMed

Recent Clinical Trials for mitoxantrone hydrochloride

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

Sponsor	Phase
Acute Leukemia French Association	Phase 2
CSPC Ouyi Pharmaceutical Co., Ltd.	N/A
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	N/A

See all mitoxantrone hydrochloride clinical trials

Pharmacology for mitoxantrone hydrochloride

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for mitoxantrone hydrochloride

Analgesics

Antineoplastic Agents

Topoisomerase II Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for mitoxantrone hydrochloride

L01DB	Anthracyclines and related substances
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for mitoxantrone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	MITOXANTRONE HYDROCHLORIDE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	076871-001	Apr 11, 2006	AP	RX	No	Yes
Hikma	MITOXANTRONE HYDROCHLORIDE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	076611-003	Apr 11, 2006	AP	RX	No	No
Fresenius Kabi Usa	MITOXANTRONE HYDROCHLORIDE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	077496-003	Apr 11, 2006	AP	RX	No	No
Hikma	MITOXANTRONE HYDROCHLORIDE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	076611-002	Apr 11, 2006	AP	RX	No	No
Fresenius Kabi Oncol	MITOXANTRONE HYDROCHLORIDE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	078606-002	May 14, 2008		DISCN	No	No
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987		DISCN	Yes	No
Fresenius Kabi Oncol	MITOXANTRONE HYDROCHLORIDE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	078606-003	May 14, 2008		DISCN	No	No

Expired US Patents for mitoxantrone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-003	Dec 23, 1987
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-002	Dec 23, 1987
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987