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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, Mylan Pharms Inc, 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 fifteen drug master file entries for cytarabine. One supplier is listed for this compound.

Summary for Generic Name: cytarabine

Drug Master File Entries: see list15
Suppliers / Packaging: 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

Courtesy of
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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eurohlth Intl Sarl
INJECTABLE;INJECTION074245-001Aug 31, 1994RXNo<disabled><disabled>
Mylan Pharms Inc
INJECTABLE;INJECTION200915-001Dec 13, 2011RXNo<disabled><disabled>
Teva Pharms Usa
INJECTABLE;INJECTION075206-004Dec 30, 1998RXYes<disabled><disabled>
INJECTABLE;INJECTION075383-001Nov 22, 1999RXNo<disabled><disabled>
INJECTABLE;INJECTION072945-001Feb 28, 1994RXYes<disabled><disabled>
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International Patent Family for Ingredient: cytarabine

Country Document Number Publication Date
Norway174087Dec 06, 1993
Norway880768Aug 24, 1988
Finland880841Aug 24, 1988
Germany3879987Jul 15, 1993
Israel85509Mar 29, 1992
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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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