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Details for Generic Name: cytarabine

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Cytarabine is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Fresenius Kabi Usa, Mylan Labs Ltd, Pacira Pharms Inc, Eurohlth Intl Sarl, Hospira, and Teva Parenteral, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: cytarabine

Tradenames:3
Patents:0
Applicants:7
NDAs:15
Drug Master File Entries: see list15
Suppliers / Packaging: see list1

Pharmacology for Ingredient: cytarabine

Clinical Trials for: cytarabine

A Phase 1b, Open-label Study of LY2510924, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Status: Not yet recruiting Condition: Leukemia

LY2606368 in Combination With Cytarabine and Fludarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (HRMDS)
Status: Not yet recruiting Condition: Leukemia

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

Courtesy of ClinicalTrials.org
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
Mylan Labs Ltd
CYTARABINE
cytarabine
INJECTABLE;INJECTION200916-001Dec 13, 2011RXNo<disabled><disabled>
Eurohlth Intl Sarl
CYTARABINE
cytarabine
INJECTABLE;INJECTION074245-001Aug 31, 1994RXNo<disabled><disabled>
Hospira
CYTARABINE
cytarabine
INJECTABLE;INJECTION072168-001Aug 31, 1990RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: cytarabine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pacira Pharms Inc
DEPOCYT
cytarabine
INJECTABLE, LIPOSOMAL;INJECTION021041-001Apr 1, 19995,455,044<disabled>
Teva Parenteral
CYTARABINE
cytarabine
INJECTABLE;INJECTION016793-002Approved Prior to Jan 1, 19823,444,294<disabled>
Pacira Pharms Inc
DEPOCYT
cytarabine
INJECTABLE, LIPOSOMAL;INJECTION021041-001Apr 1, 19995,723,147<disabled>
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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.

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Copyright 2002-2016 thinkBiotech LLC
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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