CYTARABINE Drug Patent Profile
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Which patents cover Cytarabine, and what generic alternatives are available?
Cytarabine is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Mylan Labs Ltd, Rising, Teva Parenteral, and West-ward Pharms Int. and is included in nineteen NDAs.
The generic ingredient in CYTARABINE 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 Cytarabine
A generic version of CYTARABINE was approved as cytarabine by HIKMA on August 2nd, 1989.
Summary for CYTARABINE
Recent Clinical Trials for CYTARABINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Uwe Platzbecker | Phase 2 |
Shijiazhuang Yiling Pharmaceutical Co. Ltd | Phase 3 |
Ruijin Hospital | N/A |
Pharmacology for CYTARABINE
Drug Class | Nucleoside Metabolic Inhibitor |
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for CYTARABINE
Anatomical Therapeutic Chemical (ATC) Classes 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 |