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Last Updated: December 5, 2019

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Mitoxantrone hydrochloride - Generic Drug Details

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What are the generic 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, Hospira, Mylan Institutional, Mylan Labs Ltd, Teva Pharms Usa, West-ward Pharms Int, and Emd Serono, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for mitoxantrone hydrochloride

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

SponsorPhase
Prof. Dr. Richard F SchlenkPhase 2
Delta-Fly Pharma, Inc.Phase 3
Michael BoyiadzisPhase 2

See all mitoxantrone hydrochloride clinical trials

Pharmacology for mitoxantrone hydrochloride
Medical Subject Heading (MeSH) Categories for mitoxantrone hydrochloride
Synonyms for mitoxantrone hydrochloride
1,4-dihydroxy-5,8-bis-[[2-(2-hydroxyethylamino)ethyl]amino]-anthraquinone dihydrochloride
1,4-dihydroxy-5,8-bis-[2-(2-hydroxyethylamino)ethylamino]anthraquinone 2hcl
1,4-Dihydroxy-5,8-bis-[2-(2-hydroxyethylamino)ethylamino]anthraquinone dihydrochloride
1,4-dihydroxy-5,8-bis-[2-(2-hydroxyethylamino)ethylamino]anthraquinonedihydrochloride
1,4-Dihydroxy-5,8-bis((2-((2-hydroxyethyl)amino-ethyl)amino)anthraquinone dihyrochloride
1,4-Dihydroxy-5,8-bis((2-((2-hydroxyethyl)amino)ethyl)amino)anthracene-9,10-dione dihydrochloride
1,4-Dihydroxy-5,8-bis((2-((2-hydroxyethyl)amino)ethyl)amino)anthraquinone dihydrochloride
1,4-dihydroxy-5,8-bis({2-[(2-hydroxyethyl)amino]ethyl}amino)-9,10-dihydroanthracene-9,10-dione dihydrochloride
1,4-dihydroxy-5,8-bis({2-[(2-hydroxyethyl)amino]ethyl}amino)anthracene-9,10-dione dihydrochloride
1,4-dihydroxy-5,8-bis(2-(2-hydroxyethylamino)ethylamino)anthracene-9,10-dione dihydrochloride
1,4-dihydroxy-5,8-bis[[2-(2-hydroxyethylamino)ethyl]amino]anthraquinone dihydrochloride
1,4-Dihydroxy-5,8-bis[[2-[(2-hydroxyethyl)amino]ethyl]amino]-9,10-anthracenedione dihydrochloride
1,4-Dihydroxy-5,8-bis[[2-[(2-hydroxyethyl)amino]ethyl]amino]anthraquinone dihydrochloride
1,4-dihydroxy-5,8-bis[2-(2-hydroxyethylamino)ethylamino]anthracene-9,10-dione dihydrochloride
1,4-dihydroxy-5,8-bis[2-(2-hydroxyethylamino)ethylamino]anthracene-9,10-dione;dihydrochloride
271M809
65271-80-9 (Parent)
70476-82-3
70476-82-3,65271-80-9(freebase),70711-41-0(diacetate)
9,10-Anthracenedione, 1,4-dihydroxy-5,8-bis((2-((2-hydroxyethyl)amino)ethyl)amino)-, dihydrochloride
AB0013075
AB2000351
AC-1591
AC1L1AED
AC1Q3B38
ACMC-20enxy
AK163016
AKOS015895228
AS-13162
BC215535
BCP0726000265
BCP23424
BCP9000932
Bisantrone
C22H28N4O6.2HCl
C22H30Cl2N4O6
CAS-70476-82-3
CCG-39938
CCRIS 2592
CHEBI:50727
CHEMBL1417019
CL 232,315
CL 232315
CL-232315
CS-2525
CTK8F1285
D02166
DHAD
dhaq dihydrochloride 65271-80-9
DSSTox_CID_25173
DSSTox_GSID_45173
DSSTox_RID_80722
DTXSID0045173
EINECS 274-619-1
Eslep
EU-0100779
H492
HMS1569M11
HMS1922O21
HSDB 6543
HY-13502A
I06-0260
Immunex
KS-00000XLU
LP00779
LS-20325
M 6545
MFCD00242943
mitoxanthrone hcl
MITOXANTHRONE HYDROCHLORIDE
Mitoxantrone (dihydrochloride)
Mitoxantrone 2HCl
Mitoxantrone Dihcl
Mitoxantrone dihydrochloride
Mitoxantrone dihydrochloride pound>>Mitozantrone dihydrochloride
Mitoxantrone dihydrochloride, >=97% (HPLC)
Mitoxantrone HCl
Mitoxantrone hydrochloride (JAN/USP)
Mitoxantrone hydrochloride [USAN:JAN]
Mitoxantrone hydrochloride [USAN:USP:JAN]
Mitoxantrone hydrochloride, European Pharmacopoeia (EP) Reference Standard
Mitoxantrone hydrochloride, United States Pharmacopeia (USP) Reference Standard
Mitozantrone hydrochloride
Mitroxantrone Hydrochloride
MolPort-003-665-506
NCGC00015693-02
NCGC00015693-09
NCGC00094116-01
NCGC00094116-02
NCGC00094116-03
NCGC00094116-04
NCGC00261464-01
Novantron
Novantron (TN)
Novantrone
novatrone
NSC 301739
NSC-301739
NSC-310739
NSC-310739;Novantrone
Onkotrone
Prestwick_571
Ralenova
s2485
SCHEMBL3928
SPECTRUM1503278
SR-01000076001
SR-01000076001-1
SR-01000076001-8
ST24048109
SW196745-5
TL8004973
Tox21_110197
Tox21_110197_1
Tox21_500779
TX-017757
U6USW86RD0
UNII-U6USW86RD0
W-104553
X-2300
Z2569867923
ZAHQPTJLOCWVPG-UHFFFAOYSA-N

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
Mylan Institutional MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 078980-001 Apr 13, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Institutional MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 078980-002 Apr 13, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 077496-003 Apr 11, 2006 AP RX No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Emd Serono NOVANTRONE mitoxantrone hydrochloride INJECTABLE;INJECTION 019297-001 Dec 23, 1987   Start Trial   Start Trial
Emd Serono NOVANTRONE mitoxantrone hydrochloride INJECTABLE;INJECTION 019297-003 Dec 23, 1987   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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