Vanflyta Generic: When Will Generic Quizartinib Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Vanflyta Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2033 About 7 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? September 2033 11 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic quizartinib hydrochloride is expected to be available in September 2033, about 7 years away. None is for sale yet.
Why September 2033?
It is when Vanflyta’s patent 7,820,657 ends. That patent covers the active ingredient, and once it ends, generics can go on sale as soon as the FDA approves them. It is too early to rate how firm that is.
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Vanflyta as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Vanflyta by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Not rated Too early to rate. The month is where the records point today.
- Price competition
- None filed yet No filers on record
- Brand sales
- $58M a yearSmaller seller
- FDA approved 2023 July 2023 FDA Orange Book
- Patents listed 11 last runs to September 2033 FDA Orange Book
- Medicare Part D spent $13.6M in 2025, for 171 people CMS Part D Spending by Drug
- Medicaid prescriptions 65 in the last four reported quarters, $1.6M CMS Medicaid drug utilization, to Q1 2026
Vanflyta’s Road to a Generic
Vanflyta has had the market to itself since the FDA approved it in July 2023 (Daiichi Sankyo Inc). Its FDA protection (orphan drug) runs to July 2030. Its 11 listed patents run to September 2033.
The first generic of Vanflyta is expected in September 2033.
Why that month: patent 7,820,657, on the active ingredient, ends then. That is a few months before the last listed patent runs out, in September 2033.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Vanflyta Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Vanflyta’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patent 7,820,657, which ends in September 2028; the first generic is expected after it, in September 2033, about 7 years away.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,129,374 | A way of using it (U-3661) | March 2027 | Active |
| 8,557,810 | The product’s formulation | March 2027 | Active |
| 8,883,783 | The active ingredient | March 2027 | Active |
| 9,585,892 | A way of using it (U-3661) | March 2027 | Active |
| 7,820,657 Sets the expected month of generic availability | The active ingredient | September 2028 | Active |
| 7,968,543 | The product’s formulation; a way of using it (U-3661) | August 2029 | Active |
| 8,865,710 | The product’s formulation | August 2029 | Active |
| 8,836,218 | A way of using it (U-3661) | March 2030 | Active |
| 9,555,040 | A way of using it (U-3661) | May 2030 | Active |
| 8,357,690 | A way of using it (U-3661) | February 2031 | Active |
| 9,675,549 | The product’s formulation | September 2033 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | July 2028 | Active |
| Orphan drug ODE-437 | Seven years of protection for a use in a rare disease. | July 2030 | Active |
Source: FDA Orange Book, application 216993. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Quizartinib Hydrochloride
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No company is recorded as having applied to the FDA to make a generic Vanflyta yet.
Approved by the FDA
Not yet. The FDA has not approved a generic quizartinib hydrochloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic quizartinib hydrochloride for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Vanflyta Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Vanflyta, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Vanflyta
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Vanflyta, before manufacturer rebates.
- $4M
- January to March 2026, the latest CMS has posted
For 83 people, about $21,745 per prescription fill - $13.6M
- 2025, the whole year
For 171 people, about $18,692 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $4,022,792 | 83 | $21,744.82 |
| 2025 | $13,608,109 | 171 | $18,692.46 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Vanflyta only, so no generic is counted in it. What CMS says it is used for: Quizartinib is used to treat acute myeloid leukemia (AML). It works by slowing or stopping the growth of cancer cells.
Medicaid Prescriptions by Quarter
65 prescriptions in the four quarters to Q1 2026, $1.6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 26 | $712,076 |
| Q4 2025 | 15 | $425,454 |
| Q3 2025 | 24 | $490,953 |
| Q2 2025 | 0 | $0 |
| Q1 2025 | 0 | $0 |
Source: CMS Medicaid State Drug Utilization Data, over Vanflyta’s own package codes.
Vanflyta Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 17.7MG BASE | Tablet | Oral | July 2023 | Prescription reference product |
| EQ 26.5MG BASE | Tablet | Oral | July 2023 | Prescription reference product |
Source: FDA Orange Book, Daiichi Sankyo Inc. Listed for sale today by Daiichi Sankyo Inc. (FDA NDC Directory).
Vanflyta NDC Codes and Packages
Each Vanflyta package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 65597-0504-04 | QUIZARTINIB DIHYDROCHLORIDE 17.7 mg/1 tablet, film coated | bottle of 14 tablets | Daiichi Sankyo Inc. |
| 65597-0504-04 | QUIZARTINIB DIHYDROCHLORIDE 17.7 mg/1 tablet, film coated | bottle of 14 tablets | Daiichi Sankyo Inc. |
| 65597-0504-28 | QUIZARTINIB DIHYDROCHLORIDE 17.7 mg/1 tablet, film coated | bottle of 28 tablets | Daiichi Sankyo Inc. |
| 65597-0504-28 | QUIZARTINIB DIHYDROCHLORIDE 17.7 mg/1 tablet, film coated | bottle of 28 tablets | Daiichi Sankyo Inc. |
| 65597-0511-04 | QUIZARTINIB DIHYDROCHLORIDE 26.5 mg/1 tablet, film coated | bottle of 14 tablets | Daiichi Sankyo Inc. |
| 65597-0511-04 | QUIZARTINIB DIHYDROCHLORIDE 26.5 mg/1 tablet, film coated | bottle of 14 tablets | Daiichi Sankyo Inc. |
| 65597-0511-28 | QUIZARTINIB DIHYDROCHLORIDE 26.5 mg/1 tablet, film coated | bottle of 28 tablets | Daiichi Sankyo Inc. |
| 65597-0511-28 | QUIZARTINIB DIHYDROCHLORIDE 26.5 mg/1 tablet, film coated | bottle of 28 tablets | Daiichi Sankyo Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Vanflyta’s own FDA approval (NDA 216993) are listed, never a generic. Some codes belong to companies that repackage Vanflyta: it is the same medicine in a different package.
What a Generic Vanflyta Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Vanflyta as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Vanflyta”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Vanflyta
Is there a generic for Vanflyta right now?
No. As of October 9, 2026 no generic quizartinib hydrochloride is listed for sale in the FDA NDC Directory.
When will Vanflyta go generic?
September 2033 is the expected month. It is when Vanflyta’s patent 7,820,657 ends. That patent covers the active ingredient, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic quizartinib hydrochloride be the same as Vanflyta?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Vanflyta?
Not yet. The FDA Orange Book lists no approved generic version of Vanflyta.
When does the Vanflyta patent expire?
The FDA Orange Book lists 11 patents for Vanflyta; the last runs to September 2033. The one behind the expected month is patent 7,820,657, which ends in September 2028. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (September 2033) weighs all of that.
Changes to This Projection
- First generic expected September 2033 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- SynriboOmacetaxine MepesuccinateOctober 2026
- KynamroMipomersen SodiumJanuary 2027
- XeravaEravacycline DihydrochlorideAugust 2032
- ExkivityMobocertinib SuccinateSeptember 2035
- OxlumoLumasiran2038 to 2039
- BelviqLorcaserin HydrochlorideTBD no date yet
About Vanflyta
- Generic name quizartinib hydrochloride
- How it is taken By mouth
- Company Daiichi Sankyo Inc
- More drugs Brand-name drugs starting with V
- Have a question? A pharmacist answers, free. Ask about Vanflyta
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.