You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 26, 2024

Cytarabine; daunorubicin - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

What are the generic 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-three patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for cytarabine; daunorubicin

International Patents:	143
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	278
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^: ⤷ Try a Trial* 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
Uwe Platzbecker	Phase 2
Gilead Sciences	Phase 2
Kura Oncology, Inc.	Phase 1

See all cytarabine; daunorubicin clinical trials

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ 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 cytarabine; daunorubicin

Subscribe to access the full database, or Try a Trial
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

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Canada	2467064	COMPOSITIONS A VECTEURS LIPIDIQUES A STABILITE SANGUINE ACCRUE (LIPID CARRIER COMPOSITIONS WITH ENHANCED BLOOD STABILITY)	⤷ Try a Trial
Japan	4972545		⤷ Try a Trial
European Patent Office	1432403	CHARGEMENT DE LIPOSOME AVEC DES IONS METALLIQUES (LIPOSOME LOADING WITH METAL IONS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for cytarabine; daunorubicin

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3300601	LUC00271	Luxembourg	⤷ Try a Trial	PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827
1744764	122018000134	Germany	⤷ Try a Trial	PRODUCT NAME: ZUSAMMENSETZUNG AUS DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 20180823
2768484	2019C/545	Belgium	⤷ Try a Trial	PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.