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Generated: October 23, 2018

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DOXORUBICIN HYDROCHLORIDE - Generic Drug Details

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

Doxorubicin hydrochloride is the generic ingredient in five branded drugs marketed by Janssen Res And Dev, Dr Reddys Labs Ltd, Sun Pharma Global, Pharmacia And Upjohn, Actavis Inc, Alvogen Inc, Amneal Pharms Co, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Pharmachemie Bv, Sagent Pharms, Sandoz Inc, Sun Pharm Inds, Teva Pharms Usa, West-ward Pharms Int, and Bristol Myers Squibb, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for doxorubicin hydrochloride. Sixteen suppliers are listed for this compound.

Pharmacology for DOXORUBICIN HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for DOXORUBICIN HYDROCHLORIDE
Synonyms for DOXORUBICIN HYDROCHLORIDE
(1S,3S)-3-glycoloyl-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)-7-[(2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione hydrochloride
(7S,9S)-7-[(2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione;hydrochloride
(8S-cis)-10-((3-Amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxynaphthacene-5,12-dione hydrochloride
(8S,10S)-10-(((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione hy
(8S,10S)-10-(((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione hydrochloride
(8S,10S)-10-((3-Amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-8-glycoloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride
(8S,10S)-10-{[(2R,4S,5S,6S)-4-AMINO-5-HYDROXY-6-METHYLOXAN-2-YL]OXY}-6,8,11-TRIHYDROXY-8-(2-HYDROXYACETYL)-1-METHOXY-5,7,8,9,10,12-HEXAHYDROTETRACENE-5,12-DIONE HYDROCHLORIDE
10-[(3-Amino-2,3,6-trideoxy-?-L-lyxohexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-5,12-naphthacenedione hydrochloride
139293-EP2270008A1
139293-EP2292617A1
23214-92-8 (Parent)
25316-40-9
316D409
33804-EP2275420A1
33804-EP2295055A2
33804-EP2295416A2
33804-EP2298748A2
33804-EP2298764A1
33804-EP2298765A1
33804-EP2305642A2
33804-EP2308833A2
33804-EP2311453A1
5,12-Naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)-
5,12-Naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S,10S)-
5,12-Naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S-cis)-
82F2G7BL4E
AB0069925
AC1L9FFU
Adriacin
Adriacin (TN)
Adriamycin
Adriamycin (Doxorubicin Hydrochloride
Adriamycin (TN)
ADRIAMYCIN HYDROCHLORIDE
Adriamycin hydrochloride-DNA complex
Adriamycin PFS
Adriamycin RDF
ADRIAMYCIN, HYDROCHLORIDE
Adriblastin
Adriblastina
Adriblastina hydrochloride
Adrosal
AKOS007930231
AKOS015920241
AOB5216
BCP9000237
BCPP000429
BID0120
Bio-0029
BR-72874
Caelyx
CAS-25316-40-9
CAS-NOCAS_45111
CCG-100975
CCRIS 740
CD0186
CHEBI:31522
CHEMBL359744
CPD000058570
CS-1239
D01275
D0F4KU
DOX
DOX base
Doxil (TN)
Doxorubicin (Adriamycin) HCl
Doxorubicin (hydrochloride)
Doxorubicin HCl
Doxorubicin hydrochloride (JP17/USP)
Doxorubicin hydrochloride [USP:JAN]
Doxorubicin hydrochloride solution
Doxorubicin hydrochloride, 98.0-102.0% (HPLC)
Doxorubicin hydrochloride, European Pharmacopoeia (EP) Reference Standard
Doxorubicin Hydrochloride, pharmaceutical secondary standard; traceable to USP, PhEur, BP
Doxorubicin hydrochloride, suitable for fluorescence, 98.0-102.0% (HPLC)
Doxorubicin hydrochloride, United States Pharmacopeia (USP) Reference Standard
Doxorubicin, free base
doxorubicin.HCl
DSSTox_CID_10636
DSSTox_GSID_30636
DSSTox_GSID_45111
DSSTox_RID_78854
DSSTox_RID_80678
DTXSID3030636
Duxocin
EINECS 246-818-3
EX-A1337
FT-0082477
HMS1569G18
HY-15142
Hydroxydaunorubicin hydrochloride
KSC-230-184-1
KUC110341C
KW-125
Lipo-Dox
Lipodox
MCULE-5540454667
MFCD00077757
MLS000028393
MLS000049969
MLS000049970
MLS000049971
MLS000070047
MLS000392861
MLS000392871
MLS000392881
MLS000392891
MLS000392901
MLS000759533
MLS001055359
MLS001401460
MolPort-003-933-100
MWWSFMDVAYGXBV-RUELKSSGSA-N
NC00225
NCGC00014486-01
NCGC00024415-33
NCGC00024415-36
NCGC00163543-01
NCGC00260032-01
NCGC00263918-03
NSC 123127
NSC-123127
PL010839
Prestwick_188
RL02839
Rubex
Rubex (TN)
s1208
SAM001246768
SCHEMBL3242
SMR000058570
SR-01000003049
SR-01000003049-10
ST2419270
Tox21_110050
Tox21_110050_1
Tox21_112061
Tox21_202483
UNII-82F2G7BL4E
W-5070
Z1557399790
ZX-AFC000216

US Patents and Regulatory Information for DOXORUBICIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms Int DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 062975-001 Mar 17, 1989 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmachemie Bv DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 063097-003 May 21, 1990 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacia And Upjohn DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 050467-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacia And Upjohn ADRIAMYCIN PFS doxorubicin hydrochloride INJECTABLE;INJECTION 063165-001 Jan 30, 1991 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 208657-001 May 15, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
West-ward Pharms Int DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 062921-001 Mar 17, 1989 AP RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 091418-001 Feb 15, 2012 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

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Expired US Patents for DOXORUBICIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Res And Dev DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-001 Nov 17, 1995 ➤ Sign Up ➤ Sign Up
Janssen Res And Dev DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-002 Jun 13, 2000 ➤ Sign Up ➤ Sign Up
Janssen Res And Dev DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-001 Nov 17, 1995 ➤ Sign Up ➤ Sign Up
Janssen Res And Dev DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-002 Jun 13, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Healthtrust
McKesson
Moodys
Fuji
QuintilesIMS
Johnson and Johnson
Merck
Cantor Fitzgerald

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