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Last Updated: October 20, 2019

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Epirubicin hydrochloride - Generic Drug Details

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

Epirubicin hydrochloride is the generic ingredient in two branded drugs marketed by Pfizer Inc, Actavis Totowa, Akorn Inc, Cipla Ltd, Ebewe Pharma, Fresenius Kabi Usa, Hisun Pharm Hangzhou, Hospira, Impax Labs Inc, Mustafa Nevsat, Mylan Institutional, Mylan Labs Ltd, and West-ward Pharms Int, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for epirubicin hydrochloride. Five suppliers are listed for this compound.

Recent Clinical Trials for epirubicin hydrochloride

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

SponsorPhase
Hebei Medical University Fourth HospitalN/A
Renske AltenaPhase 2
Dalian Municipal Central HospitalPhase 2

See all epirubicin hydrochloride clinical trials

Pharmacology for epirubicin hydrochloride
Medical Subject Heading (MeSH) Categories for epirubicin hydrochloride
Synonyms for epirubicin hydrochloride
(1S,3S)-3-Glycoloyl-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-arabino-hexopyranoside hydrochloride
(7S,9S)-7-[(2R,4S,5R,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,5R,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-arabino-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxynaphthacene-5,12-dione hydrochloride
(8S,10S)-10-((2R,4S,5R,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yloxy)-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione hydrochloride
22966TX7J5
33811-EP2275420A1
33811-EP2295055A2
33811-EP2295416A2
33811-EP2298748A2
33811-EP2298764A1
33811-EP2298765A1
33811-EP2305642A2
33811-EP2311453A1
4-Epidoxorubicin hydrochloride
4'-epi-Adriamycin
4'-epi-Adriamycin hydrochloride
4'-epi-Doxorubicin
4'-epi-DX
4'-Epidoxorubicin hydrochloride
5,12-Naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-L-arabino-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-arabinohexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S,10S)-
56390-09-1
56420-45-2 (Parent)
AC1L233G
AKOS030526162
BC208841
BCP9000651
BIFK0018
CCG-100950
CCRIS 4477
CHEMBL1200981
CPD000466308
CS-1773
D02214
E-ADM
EINECS 260-145-2
Ellence
Ellence (TN)
Epidoxorubicin hydrochloride
epirubicin (hydrochloride)
Epirubicin Ebewe
Epirubicin HCl
Epirubicin HCl (4'-epidoxorubicin)
Epirubicin hydrochlorid
Epirubicin hydrochloride (JP17/USAN)
Epirubicin hydrochloride [USAN:JAN]
Epirubicin hydrochloride [USAN:USP:JAN]
Epirubicin hydrochloride, >=90% (HPLC)
Epirubicin hydrochloride, British Pharmacopoeia (BP) Reference Standard
Epirubicin hydrochloride, European Pharmacopoeia (EP) Reference Standard
Epirubicin hydrochloride, United States Pharmacopeia (USP) Reference Standard
Epirubitec
EX-A2654
Farmorubicin
Farmorubicina
HY-13624A
IMI-28
LS-93989
MLS000759412
MLS001401404
MolPort-003-666-844
MWWSFMDVAYGXBV-FGBSZODSSA-N
NC00200
NSC 256942
NSC-759195
NSC759195
Pharmakon1600-01505708
Pharmorubicin
Pidorubicin
Q-101406
s1223
SAM001246559
SCHEMBL3165
SMR000466308
SR-01000763557
SR-01000763557-3
UNII-22966TX7J5

US Patents and Regulatory Information for epirubicin 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 EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065411-001 Aug 20, 2007 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065408-002 Oct 15, 2007 AP RX No No   Start Trial   Start Trial   Start Trial
Cipla Ltd EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065361-001 Oct 22, 2007 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

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