CYTOSAR-U Drug Patent Profile
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Which patents cover Cytosar-u, and what generic alternatives are available?
Cytosar-u is a drug marketed by Teva Pharms Usa and is included in one NDA.
The generic ingredient in CYTOSAR-U 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 Cytosar-u
A generic version of CYTOSAR-U was approved as cytarabine by HIKMA on August 2nd, 1989.
Summary for CYTOSAR-U
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 123 |
Clinical Trials: | 219 |
Patent Applications: | 4,541 |
Formulation / Manufacturing: | see details |
DailyMed Link: | CYTOSAR-U at DailyMed |
Recent Clinical Trials for CYTOSAR-U
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Therapeutic Advances in Childhood Leukemia Consortium | Phase 1/Phase 2 |
ADC Therapeutics | Phase 1 |
Academic and Community Cancer Research United | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for CYTOSAR-U
US Patents and Regulatory Information for CYTOSAR-U
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms Usa | CYTOSAR-U | cytarabine | INJECTABLE;INJECTION | 075206-004 | 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 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 | 075206-001 | Dec 30, 1998 | DISCN | No | 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 |
EU/EMA Drug Approvals for CYTOSAR-U
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 |