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Last Updated: November 22, 2024

MITOXANTRONE HYDROCHLORIDE - Generic Drug Details


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

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

SponsorPhase
Acute Leukemia French AssociationPhase 2
Cancer Institute and Hospital, Chinese Academy of Medical SciencesN/A
CSPC Ouyi Pharmaceutical Co., Ltd.N/A

See all MITOXANTRONE HYDROCHLORIDE clinical trials

Pharmacology for MITOXANTRONE HYDROCHLORIDE
Drug ClassTopoisomerase Inhibitor
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for MITOXANTRONE HYDROCHLORIDE

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 076871-002 Apr 11, 2006 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 201014-001 Dec 11, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 078980-002 Apr 13, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 077496-001 Apr 11, 2006 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 078980-001 Apr 13, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Meitheal MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 077356-001 Apr 11, 2006 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

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

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