Quizartinib dihydrochloride - Generic Drug Details

✉ Email this page to a colleague

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 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
Acute Leukemia French Association	Phase 2
French Innovative Leukemia Organisation	Phase 2
University Hospital Heidelberg	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	216993-002	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				⤷ 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

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Australia	2015230806	METHODS OF TREATING PROLIFERATIVE DISEASES	⤷ Sign Up
Norway	2024011		⤷ Sign Up
China	101868465	Solid forms comprising 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, compositions thereof, and uses therewith	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for quizartinib dihydrochloride

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