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Generated: June 20, 2018

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Daunorubicin hydrochloride - Generic Drug Details

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

Daunorubicin hydrochloride
is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, West-ward Pharms Int, Wyeth Ayerst, Fresenius Kabi Usa, Teva Parenteral, and Teva Pharms Usa, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for daunorubicin hydrochloride. Two suppliers are listed for this compound.
Pharmacology for daunorubicin hydrochloride
Synonyms for daunorubicin hydrochloride
(1S,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenedione, hydrochloride, (8S-cis)-
(1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranoside hydrochloride
(1S,3S)-3-acetyl-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-1-yl 3-amino-2,3,6-trideoxy-a-L-lyxo-hexopyranoside hydrochloride
(7S,9S)-9-acetyl-7-(4-amino-5-hydroxy-6-methyl-tetrahydropyran-2-yl)oxy-6,9,11-trihydroxy-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione hydrochloride
(7S,9S)-9-acetyl-7-(4-amino-5-hydroxy-6-methyloxan-2-yl)oxy-6,9,11-trihydroxy-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione hydrochloride
(7S,9S)-9-acetyl-7-[(2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyl-tetrahydropyran-2-yl]oxy-6,9,11-trihydroxy-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione hydrochloride
(7S,9S)-9-acetyl-7-[(2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione hydrochloride
(7S,9S)-9-acetyl-7-[(2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione;hydrochloride
(8S-cis)-8-Acetyl-10-[(3-amino-2,3,6-trideoxy-alpha-L-arabino-h exopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-meth oxynaphthacene-5,12-dione hydrochloride
(8S,10S)-8-acetyl-10-(((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-6,8,11-trihydroxy-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione hydrochloride
(8S,10S)-8-Acetyl-10-[(3-amino-2,3,6-trideoxy-?-L-lyxo-hexopyransoyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride
(8S,10S)-8-ACETYL-10-[(4-AMINO-5-HYDROXY-6-METHYLOXAN-2-YL)OXY]-6,8,11-TRIHYDROXY-1-METHOXY-5,7,8,9,10,12-HEXAHYDROTETRACENE-5,12-DIONE HYDROCHLORIDE
(8S,10S)-8-Acetyl-10-[[(2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]oxy]-6,8,11-trihydroxy-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione Hydrochloride
(8S,10S)-8-acetyl-10-{[(2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy}-6,8,11-trihydroxy-1-methoxy-5,7,8,9,10,12-hexahydrotetracene-5,12-dione hydrochloride
23541-50-6
3',4'-Epidaunomycin hydrochloride
5, 8-acetyl-10-[(3-amino-2,3,6-trideoxy-.alpha.-L-arabino-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, hydrochloride, (8S-cis)-
5, 8-acetyl-10-[(3-amino-2,3,6-trideoxy-.alpha.-L-lyxo-hexopyranosyl)]oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, (8S-cis)-, hydrochloride
5, 8-acetyl-10-[(3-amino-2,3,6-trideoxy-.alpha.-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, hydrochloride, (8S-cis)-
5, 8-acetyl-10-[(3-amino-2,3,6-trideoxy-.alpha.-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, hydrochloride, (8S-cis)-, mixt. with starch
5, 8-acetyl-10-[(3-amino-2,3,6-trideoxy-.alpha.-L-ribo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, hydrochloride, (8S-cis)-
5,12-Naphthacenedione, 8-acetyl-10-((3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl))oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, (8S-cis)-, hydrochloride
5,12-Naphthacenedione, 8-acetyl-10-((3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trhydroxy-1-methoxy-, hydrochloride, (8S,10S)-
5,12-Naphthacenedione, 8-acetyl-10-((3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, (8S-cis)-, hydrochloride
5,12-Naphthacenedione, 8-acetyl-10-((3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, hydrochloride, (8S,10S)-
52471-42-8
541D506
71214-33-0
AB0069872
AC1L1XQY
AC1MJ3VE
AI3-44887
AK-73029
AKOS015920259
AKOS024456618
AN-5825
AN-9538
AOB5597
API0002223
AX8041486
BID0122
BR-73029
CA000603
CAS-23541-50-6
CCG-208189
CCG-39942
CCRIS 915
Cerubidine (TN)
CHEBI:31456
CHEMBL1563
CHEMBL158918
CPD004727567
CS-1271
D01264
D4532
Daunoblastin
Daunoblastina
Daunomycin chlorohydrate
Daunomycin HCL
Daunomycin hydrochloride
Daunomycin, HCl
Daunomycin, hydrochloride
Daunorubicin (Beford)
Daunorubicin (Hydrochloride)
DAUNORUBICIN HCL
Daunorubicin HCl (Daunomycin HCl)
Daunorubicin hydrochloride (JP17/USP)
Daunorubicin hydrochloride [USAN:JAN]
Daunorubicin hydrochloride [USAN:USP:JAN]
Daunorubicin hydrochloride, >=90% (HPLC)
Daunorubicin hydrochloride, European Pharmacopoeia (EP) Reference Standard
Daunorubicin hydrochloride, meets USP testing specifications
Daunorubicin hydrochloride, United States Pharmacopeia (USP) Reference Standard
Daunorubicin, Hydrochloride
daunorubicinol hydrochloride
DSSTox_CID_13382
DSSTox_GSID_33382
DSSTox_RID_79068
DTXSID0033382
EINECS 245-723-4
FI 6339 [as the base]
FI-6339
FI-6339 [As The Base]
FT-0082464
GUGHGUXZJWAIAS-QQYBVWGSSA-N
HMS1569B15
HY-13062
KS-5149
L-lyxo-Hexopyranoside,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1a-naththacenyl 3-amino-2,3,6-trideoxy-, .alpha.-, hydrochloride
LS-59205
MFCD04974507
Mixture with Starch (MW=150,000)
MLS000069508
MLS001336042
MLS002222263
MolPort-002-498-910
MolPort-003-983-474
NCGC00024246-03
NCGC00258711-01
NDC 0082-4155
NSC-249333
NSC-257457
NSC-301724
NSC-304419
NSC-83142
NSC249333
NSC257457
NSC301724
NSC304419
NSC82151
NSC83142
Ondena
PL010689
Prestwick_791
Q716
Replaced CAS registry number(s): 62414-04-4
RP 13057 [as the base]
RP 13057 hydrochloride
RP-13057
RP-13057 [as the base]
Rubidomycin hydrochloride
Rubomycin
S-4916
s3035
SAM002589992
Same as NSC 301724, except sonicated and filtered through a 0.8 micron Millipore filter
SCHEMBL4444
SCHEMBL4445
SMR000058559
SMR000768722
SR-01000000033
SR-01000000033-6
ST2419213
ST51042193
Tox21_201159
UD984I04LZ
UNII-UD984I04LZ
WP900 hydrochloride, >=95% (HPLC), solid
ZX-AFC000806

US Patents and Regulatory Information for daunorubicin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 065000-001 May 25, 1999 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
West-ward Pharms Int DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 050731-001 Jan 30, 1998 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 065034-001 Nov 20, 2001 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Wyeth Ayerst CERUBIDINE daunorubicin hydrochloride INJECTABLE;INJECTION 050484-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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US Department of Justice
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Colorcon
Queensland Health
Harvard Business School
Julphar
Accenture
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