Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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Idarubicin hydrochloride - Generic Drug Details

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

Idarubicin hydrochloride is the generic ingredient in four branded drugs marketed by Pharmacia And Upjohn, Fresenius Kabi Usa, Mylan Labs Ltd, Sandoz, Teva Parenteral, West-ward Pharms Int, and Teva Pharms Usa, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for idarubicin hydrochloride. Three suppliers are listed for this compound.

Recent Clinical Trials for idarubicin hydrochloride

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

SponsorPhase
PETHEMA FoundationN/A
National Center for Tumor Diseases, HeidelbergPhase 2
University Hospital HeidelbergPhase 2

See all idarubicin hydrochloride clinical trials

Pharmacology for idarubicin hydrochloride
Medical Subject Heading (MeSH) Categories for idarubicin hydrochloride
Synonyms for idarubicin hydrochloride
(1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranoside, hydrochloride
(7S-cis)-9-Acetyl-7-((3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,9,11-trihydroxynaphthacene-5,12-dione hydrochloride
(7S-cis)-9-Acetyl-7-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxy-5,12-naphthacenedione
(7S-cis)-9-Acetyl-7-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxy-5,12-naphthacenedione hydrochloride
(7S,9S)-9-acetyl-7-((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yloxy)-6,9,11-trihydroxy-7,8,9,10-tetrahydrotetracene-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-8,10-dihydro-7H-tetracene-5,12-dione hydrochloride
33820-EP2275420A1
33820-EP2295055A2
33820-EP2295416A2
33820-EP2298748A2
33820-EP2298764A1
33820-EP2298765A1
33820-EP2298768A1
33820-EP2305642A2
33820-EP2311453A1
4-Demethoxydaunorubicin hydrochloride
5,12-Naphthacenedione, 9-acetyl-7-((3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,9,11-trihydroxyhydrochloride, (7S-cis)-
57852-57-0
58957-92-9 (Parent)
5VV3MDU5IE
852I570
AC-5255
AC1LCS3T
AKOS025402118
API0002971
C26H27NO9.HCl
CAS-57852-57-0
CCG-100886
CHEBI:31686
CHEMBL1200976
CPD000466355
CS-1061
D01747
Daunomycin, 4-demethoxy-, hydrochloride
DMDR
DSSTox_CID_27775
DSSTox_GSID_47797
DSSTox_RID_82550
DTXSID0047797
EINECS 260-990-7
EX-A1148
HY-17381
Idamycin
Idamycin (TN)
Idamycin PFS
Idarubicin (hydrochloride)
Idarubicin Hcl
Idarubicin hydrochlorid
Idarubicin hydrochloride (JP17/USP)
Idarubicin hydrochloride [USAN:USP:INN]
Idarubicin hydrochloride PFS
IMI 30
IMI-30
JVHPTYWUBOQMBP-RVFAQHLVSA-N
KSC-230-185-1
KUC110342C
MFCD00866457
MLS000759470
MLS001401448
MolPort-006-069-198
NC00136
NCGC00093976-03
NCGC00093976-08
Q-101407
s1228
SAM001246676
SC-25438
SCHEMBL4838
SMR000466355
SR-01000075934
SR-01000075934-5
Tox21_111236
Tox21_111236_1
UNII-5VV3MDU5IE
W-5198
Zavedos

US Patents and Regulatory Information for idarubicin 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 IDARUBICIN HYDROCHLORIDE idarubicin hydrochloride INJECTABLE;INJECTION 065288-001 May 15, 2007 AP RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa IDARUBICIN HYDROCHLORIDE PFS idarubicin hydrochloride INJECTABLE;INJECTION 065036-001 May 1, 2002 AP RX No No   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn IDAMYCIN idarubicin hydrochloride INJECTABLE;INJECTION 050661-003 Apr 25, 1995 DISCN 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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Serving leading biopharmaceutical companies globally:

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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.