QUIZARTINIB DIHYDROCHLORIDE - Generic Drug Details
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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*:
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 |
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
US Patents and Regulatory Information for QUIZARTINIB DIHYDROCHLORIDE
International Patents for QUIZARTINIB DIHYDROCHLORIDE
| 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 |
| World Intellectual Property Organization (WIPO) | 2010111172 | ⤷ Sign Up | |
| Hong Kong | 1131141 | IMIDAZOLOTHIAZOLE COMPOUNDS FOR THE TREATMENT OF DISEASE | ⤷ Sign Up |
| Japan | 2009530300 | ⤷ Sign Up | |
| Slovenia | 2001892 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for QUIZARTINIB DIHYDROCHLORIDE
| 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 |
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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.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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