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Cytarabine - Generic Drug Details

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

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:	100
Clinical Trials:	1,016
Patent Applications:	7,513
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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Labs Ltd	CYTARABINE	cytarabine	INJECTABLE;INJECTION	200916-001	Dec 13, 2011	AP	RX	No	No
Hong Kong	CYTARABINE	cytarabine	INJECTABLE;INJECTION	206190-001	Nov 9, 2017	AP	RX	No	No
West-ward Pharms Int	CYTARABINE	cytarabine	INJECTABLE;INJECTION	071471-001	Aug 2, 1989		RX	No	No
Teva Parenteral	CYTARABINE	cytarabine	INJECTABLE;INJECTION	016793-004	Dec 21, 1987		DISCN	Yes	No
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes			Y
Hospira	CYTARABINE	cytarabine	INJECTABLE;INJECTION	075383-001	Nov 22, 1999	AP	RX	No	No

Expired US Patents for cytarabine

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
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999
Teva Parenteral	CYTARABINE	cytarabine	INJECTABLE;INJECTION	016793-002	Approved Prior to Jan 1, 1982
Teva Parenteral	CYTARABINE	cytarabine	INJECTABLE;INJECTION	016793-001	Approved Prior to Jan 1, 1982
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999