VYXEOS Drug Patent Profile

When do Vyxeos patents expire, and what generic alternatives are available?

Vyxeos is a drug marketed by Celator Pharms and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and thirty-three patent family members in twenty-five countries.

The generic ingredient in VYXEOS is cytarabine; daunorubicin. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cytarabine; daunorubicin profile page.

DrugPatentWatch^® Generic Entry Outlook for Vyxeos

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VYXEOS

International Patents:	133
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	37
Patent Applications:	169
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VYXEOS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYXEOS
What excipients (inactive ingredients) are in VYXEOS?	VYXEOS excipients list
DailyMed Link:	VYXEOS at DailyMed

See drug prices for VYXEOS

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for VYXEOS

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

NDA:

209401

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 VYXEOS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Georgetown University	Phase 1/Phase 2
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1/Phase 2
H. Lee Moffitt Cancer Center and Research Institute	Phase 1

See all VYXEOS clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VYXEOS

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L01DB	Anthracyclines and related substances
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L01XY	Combinations of antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for VYXEOS

VYXEOS is protected by ten US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VYXEOS

FDA Regulatory Exclusivity protecting VYXEOS

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			Y
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes			Y
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes			Y
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes			Y

International Patents for VYXEOS

See the table below for patents covering VYXEOS around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2002340670
Japan	6359717
Australia	2002340669
Japan	2005508920
Hungary	S1900047
Japan	6133308

Supplementary Protection Certificates for VYXEOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2768484	2019/054	Ireland		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
1744764	46/2018	Austria		PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827
2768484	C20190039 00312	Estonia		PRODUCT NAME: DAUNORUBITSIIN/TSUETARABIIN;REG NO/DATE: EU/1/18/1308 27.08.2018
2768484	C201930069	Spain		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
2768484	1990053-9	Sweden		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REG. NO/DATE: EU/1/18/1308 20180827
2768484	384 1-2020	Slovakia		PRODUCT NAME: KOMBINACIA DAUNORUBICINU A CYTARABINU; REGISTRATION NO/DATE: EU/1/18/1308 20180827