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Last Updated: March 28, 2024

Cytarabine - Generic Drug Details


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What are the generic sources for cytarabine and what is the scope of freedom to operate?

Cytarabine is the generic ingredient in four branded drugs marketed by Pacira Pharms Inc, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Mylan Labs Ltd, Rising, Teva Parenteral, West-ward Pharms Int, Teva Pharms Usa, and Celator Pharms, and is included in twenty-two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for cytarabine. Five suppliers are listed for this compound.

Drug Prices for cytarabine

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Recent Clinical Trials for cytarabine

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

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

See all cytarabine clinical trials

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
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Pharms Usa CYTOSAR-U cytarabine INJECTABLE;INJECTION 075206-003 Dec 30, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa CYTOSAR-U cytarabine INJECTABLE;INJECTION 075206-002 Dec 30, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Parenteral CYTARABINE cytarabine INJECTABLE;INJECTION 016793-004 Dec 21, 1987 DISCN Yes No ⤷  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
Pacira Pharms Inc DEPOCYT cytarabine INJECTABLE, LIPOSOMAL;INJECTION 021041-001 Apr 1, 1999 ⤷  Try a Trial ⤷  Try a Trial
Teva Parenteral CYTARABINE cytarabine INJECTABLE;INJECTION 016793-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc DEPOCYT cytarabine INJECTABLE, LIPOSOMAL;INJECTION 021041-001 Apr 1, 1999 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc DEPOCYT cytarabine INJECTABLE, LIPOSOMAL;INJECTION 021041-001 Apr 1, 1999 ⤷  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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