Vanflyta is a drug owned by Daiichi Sankyo Inc. It is protected by 11 US drug patents filed in 2023 out of which none have expired yet. Vanflyta's patents will be open to challenges from 21 July, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 30, 2033. Details of Vanflyta's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7820657 | Imidazolothiazole compounds for the treatment of disease |
Sep, 2028
(3 years from now) | Active |
| US8883783 | 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 |
Mar, 2027
(2 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9675549 | Tablet containing composite with cyclodextrin |
Sep, 2033
(8 years from now) | Active |
| US8357690 | Methods of treatment using combination therapy |
Feb, 2031
(6 years from now) | Active |
| US9555040 | Methods of treating proliferative diseases |
May, 2030
(5 years from now) | Active |
| US8836218 | Methods of treatment using combination therapy |
Mar, 2030
(5 years from now) | Active |
| US7968543 | 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 |
Aug, 2029
(4 years from now) | Active |
| US8865710 | Methods of treating proliferative diseases |
Aug, 2029
(4 years from now) | Active |
| US8129374 | Method of using imidazolothiazole compounds for the treatment of disease |
Mar, 2027
(2 years from now) | Active |
| US8557810 | Imidazolothiazole compounds for the treatment of disease |
Mar, 2027
(2 years from now) | Active |
| US9585892 | 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 |
Mar, 2027
(2 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Vanflyta's patents.
Latest Legal Activities on Vanflyta's Patents
Given below is the list of recent legal activities going on the following patents of Vanflyta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jul, 2024 | US9555040 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 Jul, 2024 | US8357690 |
| Second letter to regulating agency to determine regulatory review period | 02 Feb, 2024 | US8557810 |
| Second letter to regulating agency to determine regulatory review period | 02 Feb, 2024 | US8836218 |
| Second letter to regulating agency to determine regulatory review period | 02 Feb, 2024 | US8357690 |
| Second letter to regulating agency to determine regulatory review period | 02 Feb, 2024 | US7820657 |
| Second letter to regulating agency to determine regulatory review period | 02 Feb, 2024 | US8129374 |
| Letter from FDA or Dept of Agriculture re PTE application | 24 Jan, 2024 | US7820657 |
| Letter from FDA or Dept of Agriculture re PTE application | 24 Jan, 2024 | US8129374 |
| Letter from FDA or Dept of Agriculture re PTE application | 24 Jan, 2024 | US8357690 |
FDA has granted several exclusivities to Vanflyta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vanflyta, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Vanflyta.
Exclusivity Information
Vanflyta holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Vanflyta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 20, 2028 |
| Orphan Drug Exclusivity(ODE-437) | Jul 20, 2030 |
US patents provide insights into the exclusivity only within the United States, but Vanflyta is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Vanflyta's family patents as well as insights into ongoing legal events on those patents.
Vanflyta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vanflyta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 30, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vanflyta Generics:
There are no approved generic versions for Vanflyta as of now.
About Vanflyta
Vanflyta is a drug owned by Daiichi Sankyo Inc. It is used for treatment of newly diagnosed FLT3-ITD positive acute myeloid leukemia in adult patients. Vanflyta uses Quizartinib Dihydrochloride as an active ingredient. Vanflyta was launched by Daiichi Sankyo Inc in 2023.
Approval Date:
Vanflyta was approved by FDA for market use on 20 July, 2023.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Vanflyta is 20 July, 2023, its NCE-1 date is estimated to be 21 July, 2027.
Active Ingredient:
Vanflyta uses Quizartinib Dihydrochloride as the active ingredient. Check out other Drugs and Companies using Quizartinib Dihydrochloride ingredient
Treatment:
Vanflyta is used for treatment of newly diagnosed FLT3-ITD positive acute myeloid leukemia in adult patients.
Dosage:
Vanflyta is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 26.5MG BASE | TABLET | Prescription | ORAL |
| EQ 17.7MG BASE | TABLET | Prescription | ORAL |