VANFLYTA Drug Patent Profile

Which patents cover Vanflyta, and when can generic versions of Vanflyta launch?

Vanflyta is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are eleven patents protecting this drug.

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

The generic ingredient in VANFLYTA is quizartinib dihydrochloride. One supplier is listed for this compound. Additional details are available on the quizartinib dihydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Vanflyta

Vanflyta will be eligible for patent challenges on July 20, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 20, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VANFLYTA

International Patents:	127
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	2
Patent Applications:	113
Drug Prices:	Drug price information for VANFLYTA
What excipients (inactive ingredients) are in VANFLYTA?	VANFLYTA excipients list
DailyMed Link:	VANFLYTA at DailyMed

See drug prices for VANFLYTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VANFLYTA

Constraining patent/regulatory exclusivity:

FOR USE IN COMBINATION WITH STANDARD INDUCTION AND CONSOLIDATION, AND AS MAINTENANCE THERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 INTERNAL TANDEM DUPLICATION (ITD)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST

NDA:

216993

Dosage:

TABLET;ORAL

^*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 VANFLYTA

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

Sponsor	Phase
Daiichi Sankyo, Inc.	Phase 1
Children's Oncology Group	Phase 1/Phase 2
Daiichi Sankyo, Inc.	Phase 1/Phase 2

See all VANFLYTA clinical trials

Pharmacology for VANFLYTA

Drug Class	Kinase Inhibitor
Mechanism of Action	FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors

US Patents and Regulatory Information for VANFLYTA

VANFLYTA is protected by eleven US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on FOR USE IN COMBINATION WITH STANDARD INDUCTION AND CONSOLIDATION, AND AS MAINTENANCE THERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 INTERNAL TANDEM DUPLICATION (ITD)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No	9,585,892
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes	8,129,374
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes	8,557,810		Y
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No	8,865,710		Y
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No	8,357,690
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No

International Patents for VANFLYTA

When does loss-of-exclusivity occur for VANFLYTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Hong Kong

Japan

Malaysia

Russian Federation

South Africa

South Korea

Spain

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

See the table below for additional patents covering VANFLYTA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2007227495
Brazil	PI0708823
Canada	2646437
China	101448843
Cyprus	1114099
Denmark	2001892

Supplementary Protection Certificates for VANFLYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2429524	301265	Netherlands		PRODUCT NAME: QUIZARTINIB; REGISTRATION NO/DATE: EU/1/23/1768 20231107
2429524	CA 2024 00013	Denmark		PRODUCT NAME: QUIZARTINIB; REG. NO/DATE: EU/1/23/1768 20231107
2429524	PA2024510	Lithuania		PRODUCT NAME: KVIZARTINIBAS; REGISTRATION NO/DATE: EU/1/23/1768 20231106
2410987	C202430011	Spain		PRODUCT NAME: QUIZARTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/23/1768; DATE OF AUTHORISATION: 20231106; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1768; DATE OF FIRST AUTHORISATION IN EEA: 20231106
2410987	24C1013	France		PRODUCT NAME: QUIZARTINIB; REGISTRATION NO/DATE: EU/1/23/1768 20231107
2429524	2024C/514	Belgium		PRODUCT NAME: QUIZARTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1768 20231107

DrugChatter Q&A for VANFLYTA

Vanflyta adverse reactions?
Vanflyta dose adjustments?
Vanflyta patient enrollement form?
Vanflyta prescribing information?
What are the side effects of Vanflyta?