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Mitoxantrone hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for mitoxantrone hydrochloride?

Mitoxantrone hydrochloride is the generic ingredient in two branded drugs marketed by Fresenius Kabi Oncol, West-ward Pharms Int, Mylan Labs Ltd, Teva Pharms Usa, Hospira, Mylan Institutional, Fresenius Kabi Usa, and Emd Serono, and is included in eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for mitoxantrone hydrochloride. Four suppliers are listed for this compound.

Summary for Generic Name: mitoxantrone hydrochloride

Tradenames:2
Patents:1
Applicants:8
NDAs:8
Drug Master File Entries: see list7
Suppliers / Packagers: see list4
Bulk Api Vendors: see list57
Clinical Trials: see list1,071
Patent Applications: see list7,081
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:mitoxantrone hydrochloride at DailyMed

Pharmacology for Ingredient: mitoxantrone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-002Dec 23, 1987DISCNYesNo► Subscribe► Subscribe
West-ward Pharms Int
MITOXANTRONE HYDROCHLORIDE
mitoxantrone hydrochloride
INJECTABLE;INJECTION076611-003Apr 11, 2006RXNoNo► Subscribe► Subscribe
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-003Dec 23, 1987DISCNYesNo► Subscribe► Subscribe
Fresenius Kabi Oncol
MITOXANTRONE HYDROCHLORIDE
mitoxantrone hydrochloride
INJECTABLE;INJECTION078606-003May 14, 2008DISCNNoNo► Subscribe► Subscribe
Fresenius Kabi Oncol
MITOXANTRONE HYDROCHLORIDE
mitoxantrone hydrochloride
INJECTABLE;INJECTION078606-002May 14, 2008DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: mitoxantrone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-001Dec 23, 19874,138,415► Subscribe
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-002Dec 23, 19874,820,738► Subscribe
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-001Dec 23, 19874,197,249► Subscribe
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-001Dec 23, 19874,820,738► Subscribe
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-001Dec 23, 19874,617,319► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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