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Last Updated: November 4, 2024

CYTOSAR-U Drug Patent Profile


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Which patents cover Cytosar-u, and what generic alternatives are available?

Cytosar-u is a drug marketed by Teva Pharms Usa and is included in one NDA.

The generic ingredient in CYTOSAR-U is cytarabine. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cytarabine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cytosar-u

A generic version of CYTOSAR-U was approved as cytarabine by HIKMA on August 2nd, 1989.

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Summary for CYTOSAR-U
Drug patent expirations by year for CYTOSAR-U
Recent Clinical Trials for CYTOSAR-U

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

SponsorPhase
Fred Hutchinson Cancer CenterPhase 1
ImmunoGen, Inc.Phase 1
Therapeutic Advances in Childhood Leukemia ConsortiumPhase 1/Phase 2

See all CYTOSAR-U clinical trials

US Patents and Regulatory Information for CYTOSAR-U

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa CYTOSAR-U cytarabine INJECTABLE;INJECTION 075206-004 Dec 30, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa CYTOSAR-U cytarabine INJECTABLE;INJECTION 075206-002 Dec 30, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa CYTOSAR-U cytarabine INJECTABLE;INJECTION 075206-003 Dec 30, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa CYTOSAR-U cytarabine INJECTABLE;INJECTION 075206-001 Dec 30, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for CYTOSAR-U

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pacira Limited DepoCyte cytarabine EMEA/H/C/000317
Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.
Withdrawn no no no 2001-07-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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