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Details for Generic Name: cytarabine

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Cytarabine is the generic ingredient in three branded drugs marketed by Pacira Pharms Inc, Eurohlth Intl Sarl, Fresenius Kabi Usa, Hospira, Onco Therapies Ltd, Teva Parenteral, and Teva Pharms Usa, and is included in fifteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-three patent family members in eighteen countries.

There are sixteen drug master file entries for cytarabine. One supplier is listed for this compound.

Summary for Generic Name: cytarabine

Drug Master File Entries: see list16
Suppliers: see list1
Formulation / Manufacturing:see details

Pharmacology for Ingredient: cytarabine

Clinical Trials for: cytarabine

AC220 With 5-Aza or Low Dose Cytarabine
Status: Recruiting Condition: Leukemia

Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome
Status: Recruiting Condition: Leukemia

Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS
Status: Completed Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndromes; Chronic Myelogenous Leukemia

Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
Status: Recruiting Condition: Leukemia

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
INJECTABLE;INJECTION075206-004Dec 30, 1998RXYes<disabled><disabled>
Teva Parenteral
INJECTABLE;INJECTION016793-004Dec 21, 1987DISCNNo<disabled><disabled>
Onco Therapies Ltd
INJECTABLE;INJECTION201784-001Jan 30, 2012RXNo<disabled><disabled>
Teva Parenteral
INJECTABLE;INJECTION016793-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Fresenius Kabi Usa
INJECTABLE;INJECTION076512-001Jan 15, 2004RXYes<disabled><disabled>
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International Patent Family for Ingredient: cytarabine

Country Document Number Publication Date
Austria87823Apr 15, 1993
Israel85509Aug 31, 1988
Japan2843566Jan 06, 1999
New Zealand223599Sep 26, 1990
Spain2053722Aug 01, 1994
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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