CYTARABINE - Generic Drug Details

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What are the generic drug 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, Norvium Bioscience, 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.

Summary for CYTARABINE

US Patents:	9
Tradenames:	4
Applicants:	12
NDAs:	22
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	1,314
Patent Applications:	7,503
Drug Prices:	Drug price trends for CYTARABINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CYTARABINE
What excipients (inactive ingredients) are in CYTARABINE?	CYTARABINE excipients list
DailyMed Link:	CYTARABINE at DailyMed

See drug prices for CYTARABINE

Recent Clinical Trials for CYTARABINE

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

Sponsor	Phase
Syndax Pharmaceuticals	Phase 1
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	Phase 3
Fred Hutchinson Cancer Center	Phase 1

See all CYTARABINE clinical trials

Pharmacology for CYTARABINE

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for CYTARABINE

Antimetabolites, Antineoplastic
Antiviral Agents
Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for CYTARABINE

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for CYTARABINE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	CYTARABINE	cytarabine	INJECTABLE;INJECTION	075383-001	Nov 22, 1999	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	CYTARABINE	cytarabine	INJECTABLE;INJECTION	072945-001	Feb 28, 1994	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	CYTARABINE	cytarabine	INJECTABLE;INJECTION	071472-001	Aug 2, 1989		RX	No	Yes	⤷ 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

Expired US Patents for CYTARABINE

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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	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for CYTARABINE

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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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