CYTARABINE Drug Patent Profile
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When do Cytarabine patents expire, and what generic alternatives are available?
Cytarabine is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Norvium Bioscience, 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.
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Questions you can ask:
- What is the 5 year forecast for CYTARABINE?
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- What is Average Wholesale Price for CYTARABINE?
Summary 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Parenteral | CYTARABINE | cytarabine | INJECTABLE;INJECTION | 016793-003 | Dec 21, 1987 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | CYTARABINE | cytarabine | INJECTABLE;INJECTION | 072168-001 | Aug 31, 1990 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | CYTARABINE | cytarabine | INJECTABLE;INJECTION | 071471-001 | Aug 2, 1989 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Meitheal | CYTARABINE | cytarabine | INJECTABLE;INJECTION | 208485-001 | Feb 28, 2022 | AP | RX | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Parenteral | CYTARABINE | cytarabine | INJECTABLE;INJECTION | 016793-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
