Cytarabine - Generic Drug Details

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What are the generic drug sources for cytarabine and what is the scope of freedom to operate?

Cytarabine is the generic ingredient in four branded drugs marketed by Pacira Pharms Inc, Fresenius Kabi Usa, Hong Kong, Hospira, Mylan Labs Ltd, Teva Parenteral, West-ward Pharms Int, Teva Pharms Usa, and Celator Pharms, and is included in eighteen NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for cytarabine. Four suppliers are listed for this compound.

Summary for cytarabine

US Patents:	8
Tradenames:	4
Applicants:	9
NDAs:	18
Drug Master File Entries:	15
Suppliers / Packagers:	4
Bulk Api Vendors:	102
Clinical Trials:	1,049
Patent Applications:	7,471
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for cytarabine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cytarabine
DailyMed Link:	cytarabine at DailyMed

See drug prices for cytarabine

Recent Clinical Trials for cytarabine

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

Sponsor	Phase
University Hospital Heidelberg	Phase 3
Biodesix, Inc.	Phase 2
AVEO Pharmaceuticals, Inc.	Phase 2

See all cytarabine clinical trials

Recent Litigation for cytarabine

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Auxilium Pharmaceuticals v. Upsher-Smith Laboratories	2014-01-29

See all cytarabine litigation

Pharmacology for cytarabine

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for cytarabine

Antimetabolites, Antineoplastic
Antiviral Agents
Immunosuppressive Agents

Synonyms for cytarabine

(beta-D-Arabinofuranosyl)cytosine
(non-labelled)Cytarabine-13C-15N2
04079A1RDZ
1-.beta.-D-arabinofuranosyl-cytosine
1-(arabinofuranosyl)cytosine
1-(b-D-Arabinofuranosyl)cytosine
1-(b-D-Ribofuranosyl)-2-oxo-4-amino-1,2-dihydro-1,3-diazine
1-(b-delta-Ribofuranosyl)-2-oxo-4-amino-1,2-dihydro-1,3-diazine
1-Arabinofuranosylcytosine
1-b-D-Ribofuranosylcytosine
1-b-D-ribosyl-Cytosine
1-beta -D-Arabinofaranosylcytosine
1-beta -D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-beta -d-arabinofuranosylcytosine
1-beta-arabinofuranosylcytosine
1-beta-D-Arabinofaranosylcytosine
1-beta-D-arabinofuranosyl cytosine
1-beta-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-beta-D-arabinofuranosyl-cytosine
1-beta-D-Arabinofuranosylcytosine
1-beta-D-Arabinofuranosylcytosine, Cytosine Arabinoside
1-BETA-D-ARABINOFURANOSYLCYTOSINE; ARA-C
1-beta-D-Arabinosyl-Cytosine
1-beta-D-Arabinosylcytosine
1-beta-D-ribofuranosyl-Cytosine
1-beta-delta-ribofuranosyl-Cytosine
1-beta-delta-Ribofuranosylcytosine
1-beta-delta-ribosyl-Cytosine
10163-EP2272828A1
10163-EP2284920A1
10163-EP2287165A2
10163-EP2287166A2
10163-EP2292603A1
10163-EP2292620A2
10163-EP2298764A1
10163-EP2298765A1
10163-EP2298774A1
10163-EP2299509A1
10163-EP2301921A1
10163-EP2301926A1
10163-EP2301936A1
10163-EP2308843A1
10163-EP2314558A1
10163-EP2316452A1
10163-EP2371810A1
10163-EP2372804A1
10163-EP2378585A1
147-94-4
147C944
15153-EP2270018A1
15153-EP2272832A1
15153-EP2275420A1
15153-EP2277565A2
15153-EP2277566A2
15153-EP2277567A1
15153-EP2277568A2
15153-EP2277569A2
15153-EP2277570A2
15153-EP2277865A1
15153-EP2292280A1
15153-EP2295055A2
15153-EP2295416A2
15153-EP2295426A1
15153-EP2295427A1
15153-EP2298748A2
15153-EP2298764A1
15153-EP2298765A1
15153-EP2298768A1
15153-EP2298778A1
15153-EP2298780A1
15153-EP2301928A1
15153-EP2305642A2
15153-EP2305689A1
15153-EP2308833A2
15153-EP2308855A1
15153-EP2308861A1
15153-EP2311453A1
15153-EP2311808A1
15153-EP2311825A1
15153-EP2311829A1
15153-EP2311840A1
15153-EP2311842A2
15153-EP2314590A1
15153-EP2316832A1
15153-EP2316833A1
15187-EP2270008A1
15187-EP2280012A2
15187-EP2281815A1
15187-EP2292233A2
15187-EP2292615A1
15187-EP2292617A1
15187-EP2301928A1
15187-EP2301933A1
15187-EP2305640A2
15187-EP2305671A1
15187-EP2308833A2
15187-EP2311827A1
15187-EP2311840A1
15187-EP2316832A1
15187-EP2316833A1
1beta -Arabinofuranasylcytosine
1beta -D-Arabinofuranosylcytosine
1beta -D-Arabinosylcytosine
1beta-Arabinofuranasylcytosine
1beta-D-Arabinofuranosylcytosine
1beta-D-Arabinosylcytosine
1beta-delta-Ribofuranosylcytosine
2(1H)-Pyrimidinone, 4-amino-1- -D-arabinofuranosyl
2(1H)-Pyrimidinone, 4-amino-1-.beta.-D-arabinofuranosyl-
2(1H)-Pyrimidinone, 4-amino-1-\|A-D-arabinofuranosyl-
2(1H)-Pyrimidinone, 4-amino-1-beta -D-arabinofuranosyl-
2(1H)-Pyrimidinone, 4-amino-1-beta-D-arabinofuranosyl-
2(1H)-Pyrimidinone, 4-amino-1-y-D-arabinofuranosyl- [CAS]
2(1H)-Pyrimidinone, 4-amino-1beta -D-arabinofuranosyl-
4-Amino-1-((2R,3S,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2(1H)-one
4-amino-1-[(2R,3S,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,2-dihydropyrimidin-2-one
4-amino-1-[(2R,3S,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one
4-amino-1-[(2R,3S,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]pyrimidin-2-one
4-Amino-1-arabinofuranosyl-2-oxo-1,2-dihydropyrimidin
4-Amino-1-arabinofuranosyl-2-oxo-1,2-dihydropyrimidin [Czech]
4-Amino-1-arabinofuranosyl-2-oxo-1,2-dihydropyrimidine
4-Amino-1-b-D-arabinofuranosyl-2-(1H)-pyrimidinone
4-Amino-1-b-D-ribofuranosyl-2(1H)-pyrimidinone
4-Amino-1-beta-D-arabinofuranosyl-2(1H)-pyrimidinon
4-Amino-1-beta-D-arabinofuranosyl-2(1H)-pyrimidinon [Czech]
4-Amino-1-beta-D-arabinofuranosyl-2(1H)-pyrimidinone
4-amino-1-beta-D-arabinofuranosylpyrimidin-2(1H)-one
4-Amino-1-beta-delta-ribofuranosyl-2(1H)-pyrimidinone
69-74-9 (hydrochloride)
AB0005212
AC-1075
AC1L1M4F
AC1Q52OJ
AI3-52329
AJ-45634
AK-54744
AKOS007930145
AKOS015896896
Alexan
AM84428
ANW-58969
AR3
Ara-C
Ara-Cytidine
Arabinocytidine
arabinocytosine
Arabinofuranosylcytosine
Arabinoside C
Arabinosyl Cytosine
Arabinosylcytosine
Arabitin
AraC
Aracytidine
Aracytin
Aracytine
Arafcyt
AX8008499
BCP02876
BDBM50087289
beta -arabinosylcytosine
beta -cytosine arabinoside
beta -D-arabinosylcytosine
beta-Ara C
beta-Arabinosylcytosine
Beta-cytosine arabinoside
beta-D-Arabinosylcytosine
BIDD:GT0371
BIDD:PXR0139
BRD-K33106058-001-07-7
BRD-K33106058-003-20-6
C-55053
C02961
C9H13N3O5
CAS-147-94-4
CCG-51297
CCRIS 913
CHEBI:28680
CHEMBL803
CHX 3311
Citarabina
Citarabina [INN-Spanish]
CPD000449317
CS-2177
CTK8B7927
Cytarabin
Cytarabina
Cytarabine (JP17/USP/INN)
CYTARABINE (SEE ALSO CYTARABINE HYDROCHLORIDE 69-74-9)
Cytarabine [USAN:INN:BAN:JAN]
Cytarabine [USAN:USP:INN:BAN:JAN]
cytarabine liposome injection
Cytarabine, 98%
Cytarabine, European Pharmacopoeia (EP) Reference Standard
Cytarabine, Pharmaceutical Secondary Standard; Certified Reference Material
Cytarabine, United States Pharmacopeia (USP) Reference Standard
Cytarabine; 2(1H)-Pyrimidinone,4-amino-1-a-Darabinofuranosyl-
Cytarabinoside
Cytarabinum
Cytarabinum [INN-Latin]
Cytarbel
Cytartbine
Cytonal
Cytosar
Cytosar-U
Cytosine 1-beta-D-arabinofuranoside
Cytosine arabinofuranoside
Cytosine arabinose
Cytosine arabinoside
Cytosine arabinoside (VAN)
Cytosine beta-D-arabinofuranoside
Cytosine beta-D-arabinofuranoside, crystalline, >=90% (HPLC)
Cytosine beta-D-arabinofuranoside, Vetec(TM) reagent grade, 90%
Cytosine beta-D-arabinoside
Cytosine-1-beta-D-arabinofuranoside
cytosine-1b-D-Ribofuranoside
cytosine-1b-delta-Ribofuranoside
cytosine-1beta-delta-Ribofuranoside
Cytosine-beta -arabinoside
Cytosine-beta -D-arabinofuranoside
Cytosine-beta-arabinoside
Cytosine-beta-D-arabinofuranoside
Cytosine, 1-beta -D-arabinofuranosyl-
Cytosine, 1-beta -D-arabinosyl-
Cytosine, 1-beta-D-arabinofuranosyl-
Cytosine, 1-beta-D-arabinosyl-
Cytosine, beta -D-arabinoside
Cytosine, beta-D-arabinoside
Cytosinearabinoside
D00168
DB00987
Depocyt
Depocyt (liposomal)
Depocyt (TN)
DepoCyte
DSSTox_CID_2877
DSSTox_GSID_22877
DSSTox_RID_76771
DTXSID3022877
EBD145460
EINECS 205-705-9
Erpalfa
FT-0082880
FT-0624314
GP6403
GTPL4827
HMS2051K19
HMS2090A18
HMS2230M16
HMS3713N12
HSDB 3049
HY-13605
Intrathecal (injected into the spinal fluid) DepoCyt
Intrathecal cytarabine (also known as ara-C)
Iretin
J-520199
J-700005
J-700166
J10463
K-4708
KB-09511
KS-0000022L
KS-5063
KSC917S2P
Lopac0_000316
LS-860
MCULE-3945147956
MFCD00066487
MK 8242
MLS000758310
MLS001066340
MLS001424023
MolPort-001-792-509
NC00070
NCGC00093356-03
NCGC00093356-04
NCGC00093356-05
NCGC00093356-06
NCGC00142483-02
NCGC00255381-01
NCI-C04728
NSC 287459
NSC287459
PubChem14152
PYR287
RL01868
s1648
SAM001247012
SCHEMBL3140
SL-000002
SMR000449317
Spongocytidine
SR-01000075773
SR-01000075773-3
SR-01000075773-5
SR-01000721860
SR-01000721860-6
SRI-10828_24
SRI-10828-19
SRI-10828-20
ST24043183
SW197450-5
Tarabine
TL8001048
Tox21_111203
Tox21_301971
TR-008148
U 19920A
U-19,920
U-19920
Udicil
UHDGCWIWMRVCDJ-CCXZUQQUSA-N
UNII-04079A1RDZ
Z1522566619
ZINC3795098

US Patents and Regulatory Information for cytarabine

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Glossary

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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	CYTARABINE	cytarabine	INJECTABLE;INJECTION	071471-001	Aug 2, 1989		RX	No	No	Start Trial	Start Trial				Start Trial
Hospira	CYTARABINE	cytarabine	INJECTABLE;INJECTION	072945-001	Feb 28, 1994	AP	RX	No	Yes	Start Trial	Start Trial				Start Trial
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Hospira	CYTARABINE	cytarabine	INJECTABLE;INJECTION	071868-001	Jun 4, 1990	AP	RX	No	Yes	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 cytarabine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	Start Trial	Start Trial
Teva Parenteral	CYTARABINE	cytarabine	INJECTABLE;INJECTION	016793-002	Approved Prior to Jan 1, 1982	Start Trial	Start Trial
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	Start Trial	Start Trial
Teva Parenteral	CYTARABINE	cytarabine	INJECTABLE;INJECTION	016793-001	Approved Prior to Jan 1, 1982	Start Trial	Start Trial
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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