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: | 32 |
| 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 |
|---|---|
| Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Phase 3 |
| University Hospital Heidelberg | Phase 3 |
| Daiichi Sankyo Co., Ltd. | Early Phase 1 |
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 |
|---|---|---|---|
| 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 | ⤷ Try a Trial |
| European Patent Office | 2596795 | Procédés d'administration de n- (5-tert-butyl-isoxazol-3-yl) -n? - {4- [7- (2-morpholin -4-yl-éthoxy) imidazo [2,1-b] [1,3] benzothiazol-2-yl] phényl}urée pour traiter une maladie proliférante (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) | ⤷ Try a Trial |
| Australia | 2010248860 | Methods of treating proliferative diseases | ⤷ Try a Trial |
| China | 102438588 | Methods of treatment using combination therapy | ⤷ Try a Trial |
| Poland | 2201018 | ⤷ Try a Trial | |
| Spain | 2681529 | ⤷ Try a Trial | |
| 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) | ⤷ Try a Trial |
| >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 | ⤷ Try a Trial | PRODUCT NAME: QUIZARTINIB; REG. NO/DATE: EU/1/23/1768 20231107 |
| 2429524 | PA2024510 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: KVIZARTINIBAS; REGISTRATION NO/DATE: EU/1/23/1768 20231106 |
| 2429524 | 301265 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: QUIZARTINIB; REGISTRATION NO/DATE: EU/1/23/1768 20231107 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
