Veozah Generic: When Will Generic Fezolinetant Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Veozah Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? May 2037 About 10.5 years away Why then?
  2. Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
  3. When does the last patent end? March 2034 4 patents listed with the FDA
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic fezolinetant is expected to be available in May 2037, about 10.5 years away. None is for sale yet.

Why May 2037?

It is when Veozah’s patent 9,422,299 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.

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 Veozah 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.

Veozah by the Numbers

Reason
Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
How sure
Probable More likely than not, but it can still move.
Price competition
None filed yet No filers on record
Brand sales
$439M a yearBig seller
  • FDA approved 2023 May 2023 FDA Orange Book
  • Patents listed 4 last runs to March 2034 FDA Orange Book
  • Pharmacies pay $18.58 per tablet, up 6% in a year NADAC, October 2026
  • Medicare Part D spent $76.5M in 2025, for 22.9K people CMS Part D Spending by Drug
  • Medicaid prescriptions 81.4K in the last four reported quarters, $50.2M CMS Medicaid drug utilization, to Q1 2026

Veozah’s Road to a Generic

Veozah has had the market to itself since the FDA approved it in May 2023 (Astellas Pharma US Inc). Its FDA protection (new chemical entity) runs to May 2028. Its 4 listed patents run to March 2034.

The first generic of Veozah is expected in May 2037.

Why that month: patent 9,422,299, on the active ingredient, the product’s formulation and a way of using it, ends then.

Brand alone on the market Since FDA approval, May 2023
New chemical entity Ends May 2028
Patent 8,871,761 Expires April 2031
Patent 9,422,299 Expires March 2034 The patent behind the expected month of generic availability
Patent 9,987,274 Expires March 2034
Patent 10,836,768 Expires March 2034
Brand alone on the market FDA exclusivity Patent on the active ingredient Patent on a use First generic expected Swipe the chart sideways to see every year.

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.

Veozah Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Veozah’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 9,422,299, which ends in March 2034; the first generic is expected after it, in May 2037, about 10.5 years away.

Patents listed with the FDA (4)
PatentWhat it coversProtects untilStatus
8,871,761 The active ingredient April 2031 Active
9,422,299 Sets the expected month of generic availability The active ingredient; the product’s formulation; a way of using it (U-3622) March 2034 Active
9,987,274 A way of using it (U-3622) March 2034 Active
10,836,768 A way of using it (U-3622) March 2034 Active
FDA exclusivities (1)
ExclusivityWhat it meansEndsStatus
New chemical entity NCEFive years of protection for a medicine whose active ingredient the FDA had never approved before.May 2028Active

Source: FDA Orange Book, application 216578. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Fezolinetant

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.

1

Applied to the FDA

No company is recorded as having applied to the FDA to make a generic Veozah yet.

2

Approved by the FDA

Not yet. The FDA has not approved a generic fezolinetant. Final approval often comes close to the day a generic can be sold.

3

For Sale in Pharmacies

Not yet. No company lists a generic fezolinetant 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).

Veozah Price: What Pharmacies Pay and What Generics Usually Do

What Pharmacies Pay for Veozah 45 mg tablet

$18.58 per tablet in October 2026, up 6% from a year earlier.

Hover over or tap anywhere on the chart to see that month’s price.

See the numbers
MonthPharmacies paid per tablet
October 2026$18.58
September 2026$18.58
August 2026$18.59
July 2026$18.59
June 2026$18.59
May 2026$18.59
April 2026$18.63
March 2026$18.63
February 2026$18.63
January 2026$18.63
February 2024$17.53
January 2024$17.53

NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.

What a Generic Could Cost

How we estimate it. We start from what pharmacies pay for Veozah today: $18.58 per tablet for Veozah 45 mg tablet in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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).

Dollar figures apply FDA’s median drops to the $18.58 pharmacies pay per tablet today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.

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 Veozah

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 Veozah, before manufacturer rebates.

$21.9M
January to March 2026, the latest CMS has posted
For 16,409 people, about $714 per prescription fill
$76.5M
2025, the whole year
For 22,946 people, about $704 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$21,850,97716,409$714.25
2025$76,543,48622,946$704.47

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Veozah only, so no generic is counted in it. What CMS says it is used for: This medication is used to help reduce certain symptoms of menopause (such as hot flashes, night sweats). Fezolinetant works by blocking a certain chemical (neurokinin B-NKB) in the temperature control area of the brain that can cause hot flashes and night sweats.

Medicaid Prescriptions by Quarter

81,386 prescriptions in the four quarters to Q1 2026, $50.2M paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 202620,729$13,071,809
Q4 202521,233$13,063,799
Q3 202520,871$12,829,093
Q2 202518,553$11,211,017
Q1 202516,798$10,067,495

Source: CMS Medicaid State Drug Utilization Data, over Veozah’s own package codes.

Veozah Strengths and Forms

StrengthFormHow it is takenApprovedStatus
45MGTabletOralMay 2023Prescription reference product

Source: FDA Orange Book, Astellas Pharma US Inc. Listed for sale today by Astellas Pharma US, Inc. (FDA NDC Directory).

Veozah NDC Codes and Packages

Each Veozah 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.

Veozah packages (8)
NDCProductPackageCompany
00469-2460-28FEZOLINETANT 45 mg/1 tablet, film coatedtray of 4 cartons of 1 bottle of 7 tabletsAstellas Pharma US, Inc.
00469-2460-28FEZOLINETANT 45 mg/1 tablet, film coatedtray of 4 cartons of 1 bottle of 7 tabletsAstellas Pharma US, Inc.
00469-2660-30FEZOLINETANT 45 mg/1 tablet, film coatedbottle of 30 tabletsAstellas Pharma US, Inc.
00469-2660-30FEZOLINETANT 45 mg/1 tablet, film coatedbottle of 30 tabletsAstellas Pharma US, Inc.
00469-2660-90FEZOLINETANT 45 mg/1 tablet, film coatedbottle of 90 tabletsAstellas Pharma US, Inc.
00469-2660-90FEZOLINETANT 45 mg/1 tablet, film coatedbottle of 90 tabletsAstellas Pharma US, Inc.
00469-2760-28FEZOLINETANT 45 mg/1 tablet, film coatedtray of 4 cartons of 1 blister pack of 7 tabletsAstellas Pharma US, Inc.
00469-2760-28FEZOLINETANT 45 mg/1 tablet, film coatedtray of 4 cartons of 1 blister pack of 7 tabletsAstellas Pharma US, Inc.

Source: the FDA NDC Directory, current listings only. Only packages sold under Veozah’s own FDA approval (NDA 216578) are listed, never a generic. Some codes belong to companies that repackage Veozah: it is the same medicine in a different package.

What a Generic Veozah Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Veozah 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 Veozah”. 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 Veozah

Is there a generic for Veozah right now?

No. As of October 9, 2026 no generic fezolinetant is listed for sale in the FDA NDC Directory.

When will Veozah go generic?

May 2037 is the expected month, and that is probable but not certain. It is when Veozah’s patent 9,422,299 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.

Will generic fezolinetant be the same as Veozah?

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 Veozah?

Not yet. The FDA Orange Book lists no approved generic version of Veozah.

When does the Veozah patent expire?

The FDA Orange Book lists 4 patents for Veozah; the last runs to March 2034. The one behind the expected month is patent 9,422,299, which ends in March 2034. 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 (May 2037) weighs all of that.

How much does Veozah cost now?

Pharmacies paid about $18.58 per tablet for Veozah 45 mg tablet in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.

Changes to This Projection

  • First generic expected May 2037 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

All upcoming generics

About Veozah

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, NADAC (CMS), 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.