Quizartinib dihydrochloride - Generic Drug Details

What are the generic sources for quizartinib dihydrochloride and what is the scope of freedom to operate?

Quizartinib dihydrochloride is the generic ingredient in one branded drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Quizartinib dihydrochloride has one hundred and seventeen patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for quizartinib dihydrochloride

International Patents:	117
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	32
Patent Applications:	62
DailyMed Link:	quizartinib dihydrochloride at DailyMed

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

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

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 quizartinib dihydrochloride

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

Sponsor	Phase
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company	Phase 3
University Hospital Heidelberg	Phase 3
Daiichi Sankyo Co., Ltd.	Early Phase 1

See all quizartinib dihydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for quizartinib dihydrochloride

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for quizartinib dihydrochloride

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
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes			Y
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No

International Patents for quizartinib dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0708823	composto, mÉtodos para tratar uma doenÇa proliferativa, uma doenÇa autoimune e uma doenÇa inflamatària em um paciente, e, composiÇço
Canada	2646437	COMPOSES D'IMIDAZOLOTHIAZOLE POUR LE TRAITEMENT DE MALADIES (IMIDAZOLOTHIAZOLE COMPOUNDS FOR THE TREATMENT OF DISEASE)
Spain	2436266
Canada	2761940	METHODES DE TRAITEMENT DE MALADIES PROLIFERATIVES (METHODS OF TREATING PROLIFERATIVE DISEASES)
Russian Federation	2011142750	СПОСОБ ЛЕЧЕНИЯ ПУТЕМ ПРИМЕНЕНИЯ КОМБИНИРОВАННОЙ ТЕРАПИИ
Israel	194076	תרכובות בנזו-[d]-אימידזו[2, 1-b]תיאזול-2-אילפניל לטיפול במחלה (Benzo[d]imidazo[2,1-b]thiazol-2-ylphenyl compounds for the treatment of disease)