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Last Updated: March 29, 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 freedom to operate?

Mitoxantrone hydrochloride is the generic ingredient in two branded drugs marketed by Fresenius Kabi Oncol, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, Mylan Labs Ltd, 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
Recent Clinical Trials for mitoxantrone hydrochloride

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

SponsorPhase
Pediatric Oncology Experimental Therapeutics Investigators' ConsortiumPhase 1/Phase 2
Lucile Packard Children's Hospital FoundationPhase 1/Phase 2
Stanford UniversityPhase 1/Phase 2

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
Meitheal MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 077356-002 Apr 11, 2006 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Emd Serono NOVANTRONE mitoxantrone hydrochloride INJECTABLE;INJECTION 019297-001 Dec 23, 1987 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 076871-002 Apr 11, 2006 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 076611-003 Apr 11, 2006 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Oncol MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 078606-001 May 14, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 077356-003 Apr 11, 2006 AP RX 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

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

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