Quizartinib dihydrochloride - Generic Drug Details

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What are the generic drug 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 nineteen patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for quizartinib dihydrochloride

International Patents:	119
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	33
Patent Applications:	62
DailyMed Link:	quizartinib dihydrochloride at DailyMed

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

Generic Entry Date for quizartinib dihydrochloride^: ⤷ Sign Up* 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
French Innovative Leukemia Organisation	Phase 2
Acute Leukemia French Association	Phase 2
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company	Phase 3

See all quizartinib dihydrochloride clinical trials

Pharmacology for quizartinib dihydrochloride

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

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for quizartinib dihydrochloride

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Country	Patent Number	Title	Estimated Expiration
Taiwan	200924756	Methods of administering N-(5-tert-butyl-isoxazol-3-yl)-N'-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea to treat proliferative disease	⤷ Sign Up
Poland	2205244		⤷ Sign Up
Russian Federation	2543348	СПОСОБ ЛЕЧЕНИЯ ПУТЕМ ПРИМЕНЕНИЯ КОМБИНИРОВАННОЙ ТЕРАПИИ (METHOD OF TREATMENT BY APPLICATION OF COMBINED THERAPY)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for quizartinib dihydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2429524	301265	Netherlands	⤷ Sign Up	PRODUCT NAME: QUIZARTINIB; REGISTRATION NO/DATE: EU/1/23/1768 20231107
2429524	PA2024510	Lithuania	⤷ Sign Up	PRODUCT NAME: KVIZARTINIBAS; REGISTRATION NO/DATE: EU/1/23/1768 20231106
2429524	CA 2024 00013	Denmark	⤷ Sign Up	PRODUCT NAME: QUIZARTINIB; REG. NO/DATE: EU/1/23/1768 20231107
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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