VANFLYTA Drug Patent Profile
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Which patents cover Vanflyta, and when can generic versions of Vanflyta launch?
Vanflyta is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are eleven patents protecting this drug.
This drug has one hundred and nineteen patent family members in twenty-nine countries.
The generic ingredient in VANFLYTA is quizartinib dihydrochloride. One supplier is listed for this compound. Additional details are available on the quizartinib dihydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Vanflyta
Vanflyta will be eligible for patent challenges on July 20, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 20, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for VANFLYTA
| International Patents: | 119 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 124 |
| Clinical Trials: | 2 |
| Patent Applications: | 33 |
| Drug Prices: | Drug price information for VANFLYTA |
| What excipients (inactive ingredients) are in VANFLYTA? | VANFLYTA excipients list |
| DailyMed Link: | VANFLYTA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VANFLYTA
Generic Entry Date for VANFLYTA*:
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 NDA:
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 VANFLYTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Daiichi Sankyo, Inc. | Phase 1 |
| Children's Oncology Group | Phase 1/Phase 2 |
| Daiichi Sankyo, Inc. | Phase 1/Phase 2 |
Pharmacology for VANFLYTA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors |
US Patents and Regulatory Information for VANFLYTA
VANFLYTA is protected by eleven US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VANFLYTA is ⤷ Sign Up.
This potential generic entry date is based on 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.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting VANFLYTA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: COMBINATION WITH STANDARD CYTARABINE AND ANTHRACYCLINE INDUCTION AND CYTARABINE CONSOLIDATION, AND AS MAINTENANCE MONOTHERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD POSITIVE ACUTE MYELOID LEUKEMIA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: COMBINATION WITH STANDARD CYTARABINE AND ANTHRACYCLINE INDUCTION AND CYTARABINE CONSOLIDATION, AND AS MAINTENANCE MONOTHERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD POSITIVE ACUTE MYELOID LEUKEMIA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: COMBINATION WITH STANDARD CYTARABINE AND ANTHRACYCLINE INDUCTION AND CYTARABINE CONSOLIDATION, AND AS MAINTENANCE MONOTHERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD POSITIVE ACUTE MYELOID LEUKEMIA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: COMBINATION WITH STANDARD CYTARABINE AND ANTHRACYCLINE INDUCTION AND CYTARABINE CONSOLIDATION, AND AS MAINTENANCE MONOTHERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD POSITIVE ACUTE MYELOID LEUKEMIA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: COMBINATION WITH STANDARD CYTARABINE AND ANTHRACYCLINE INDUCTION AND CYTARABINE CONSOLIDATION, AND AS MAINTENANCE MONOTHERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD POSITIVE ACUTE MYELOID LEUKEMIA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: COMBINATION WITH STANDARD CYTARABINE AND ANTHRACYCLINE INDUCTION AND CYTARABINE CONSOLIDATION, AND AS MAINTENANCE MONOTHERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD POSITIVE ACUTE MYELOID LEUKEMIA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting VANFLYTA
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
Exclusivity Expiration: ⤷ Sign Up
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ 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 | 216993-001 | 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 VANFLYTA
See the table below for patents covering VANFLYTA around the world.
| 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 VANFLYTA
| 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.
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