CYTARABINE; DAUNORUBICIN - Generic Drug Details
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What are the generic drug sources for cytarabine; daunorubicin and what is the scope of patent protection?
Cytarabine; daunorubicin
is the generic ingredient in one branded drug marketed by Celator Pharms and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Cytarabine; daunorubicin has one hundred and forty-five patent family members in twenty-six countries.
One supplier is listed for this compound.
Summary for CYTARABINE; DAUNORUBICIN
| International Patents: | 145 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 280 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CYTARABINE; DAUNORUBICIN |
| DailyMed Link: | CYTARABINE; DAUNORUBICIN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CYTARABINE; DAUNORUBICIN
Generic Entry Date for CYTARABINE; DAUNORUBICIN*:
Constraining patent/regulatory exclusivity:
TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for CYTARABINE; DAUNORUBICIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | Phase 3 |
| Gilead Sciences | Phase 2 |
| Uwe Platzbecker | Phase 2 |
Pharmacology for CYTARABINE; DAUNORUBICIN
| Drug Class | Anthracycline Topoisomerase Inhibitor Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors Topoisomerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for CYTARABINE; DAUNORUBICIN
US Patents and Regulatory Information for CYTARABINE; DAUNORUBICIN
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Celator Pharms | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401-001 | Aug 3, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Celator Pharms | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401-001 | Aug 3, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Celator Pharms | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401-001 | Aug 3, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Celator Pharms | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401-001 | Aug 3, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Celator Pharms | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401-001 | Aug 3, 2017 | RX | Yes | 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 |
EU/EMA Drug Approvals for CYTARABINE; DAUNORUBICIN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Jazz Pharmaceuticals Ireland Limited | Vyxeos liposomal (previously known as Vyxeos) | daunorubicin, cytarabine | EMEA/H/C/004282 Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). |
Authorised | no | no | yes | 2018-08-23 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for CYTARABINE; DAUNORUBICIN
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20100014441 | FIXED DRUG RATIOS FOR TREATMENT OF HEMATOPOIETIC CANCERS AND PROLIFERATIVE DISORDERS | ⤷ Sign Up |
| Hong Kong | 1201039 | 凍幹脂質體 (LYOPHILIZED LIPOSOMES) | ⤷ Sign Up |
| Japan | 2010018632 | LIPID CARRIER COMPOSITION HAVING ENHANCED STABILITY IN BLOOD | ⤷ Sign Up |
| Japan | 2006523713 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2004093795 | ⤷ Sign Up | |
| Israel | 232161 | ליפוסומים שעברו ליופיליזציה ושיטות להכנתם (Lyophilized liposomes and methods of preparing same) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CYTARABINE; DAUNORUBICIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2768484 | 2019/054 | Ireland | ⤷ Sign Up | PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827 |
| 2768484 | 384 1-2020 | Slovakia | ⤷ Sign Up | PRODUCT NAME: KOMBINACIA DAUNORUBICINU A CYTARABINU; REGISTRATION NO/DATE: EU/1/18/1308 20180827 |
| 2768484 | C201930069 | Spain | ⤷ Sign Up | PRODUCT NAME: COMBINACION DE DAUNORUBICINA Y CITARABINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1308; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1308; DATE OF FIRST AUTHORISATION IN EEA: 20180823 |
| 3300601 | CA 2022 00030 | Denmark | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AF DAUNORUBICIN OG CYTARABIN; REG. NO/DATE: EU/1/18/1308 20180827 |
| 3300601 | 2022C/528 | Belgium | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827 |
| 1744764 | 300960 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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