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Last Updated: March 28, 2024

CYTARABINE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Cytarabine

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

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Drug patent expirations by year for CYTARABINE
Drug Prices for CYTARABINE

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Recent Clinical Trials for CYTARABINE

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SponsorPhase
Uwe PlatzbeckerPhase 2
Shijiazhuang Yiling Pharmaceutical Co. LtdPhase 3
Ruijin HospitalN/A

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Pharmacology for CYTARABINE
Medical Subject Heading (MeSH) Categories for CYTARABINE

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
Fresenius Kabi Usa CYTARABINE cytarabine INJECTABLE;INJECTION 076512-001 Jan 15, 2004 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Parenteral CYTARABINE cytarabine INJECTABLE;INJECTION 016793-003 Dec 21, 1987 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira CYTARABINE cytarabine INJECTABLE;INJECTION 072168-001 Aug 31, 1990 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma CYTARABINE cytarabine INJECTABLE;INJECTION 071471-001 Aug 2, 1989 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal CYTARABINE cytarabine INJECTABLE;INJECTION 208485-001 Feb 28, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Parenteral CYTARABINE cytarabine INJECTABLE;INJECTION 016793-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira CYTARABINE cytarabine INJECTABLE;INJECTION 072945-001 Feb 28, 1994 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CYTARABINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Parenteral CYTARABINE cytarabine INJECTABLE;INJECTION 016793-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Teva Parenteral CYTARABINE cytarabine INJECTABLE;INJECTION 016793-002 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for CYTARABINE

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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