Klisyri Generic: When Will Generic Tirbanibulin 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
Klisyri Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2035 to 2036 A wide window 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 2038 7 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic tirbanibulin is expected to be available between 2035 and 2036. None is for sale yet.
Why 2035 to 2036?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If Klisyri’s last patent runs to September 2038, how can a generic come sooner?
The 4 patents that run past the expected month, to September 2038 (10,617,693, 11,497,750, 12,667,576 and 10,669,236), cover a way of using it, the active ingredient and the product’s formulation. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. Here, a settlement between the companies sets the date. Generic companies have been challenging Klisyri’s patents with the FDA since December 2024. That is why the expected month comes before the last protection ends. See the road to a generic
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, and more so as more companies sell one. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. See the price pattern
What should I do now?
Keep taking Klisyri 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.
Klisyri by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- $27M a yearSmaller seller
- FDA approved 2020 December 2020 FDA Orange Book
- Patents listed 7 last runs to September 2038 A generic is expected sooner, between 2035 and 2036. See why FDA Orange Book
- Medicare Part D spent $4.6M in 2025, for 2,540 people CMS Part D Spending by Drug
Klisyri’s Road to a Generic
Klisyri has had the market to itself since the FDA approved it in December 2020 (Almirall LLC). Its FDA protection (new dosing) runs to June 2027. Its 7 listed patents run to September 2038. Generic companies have challenged its patents with the FDA since December 2024.
The first generic of Klisyri is expected between 2035 and 2036.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before September 2038
The last listed patent runs to September 2038; a court ruling or a settlement can bring a generic sooner. Dr. Brian explains
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.
Klisyri Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Klisyri’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,323,001 | The product’s formulation | December 2027 | Active |
| 7,851,470 | The active ingredient; the product’s formulation; a way of using it (U-3015) | February 2029 | Active |
| 7,300,931 | The active ingredient; the product’s formulation | December 2030 | Active |
| 10,617,693 | A way of using it (U-3015) | March 2038 | Active |
| 11,497,750 | A way of using it (U-3015) | March 2038 | Active |
| 12,667,576 | A way of using it (U-4577) | March 2038 | Active |
| 10,669,236 | The active ingredient; the product’s formulation | September 2038 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New dosing D-192 | Three years of protection for a new way of dosing it. | June 2027 | Active |
Source: FDA Orange Book, application 213189. Patent numbers open the patent on Google Patents.
Patent Challenges to Klisyri
The first patent challenge to Klisyri reached the FDA in December 2024, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Klisyri’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Ointment, 0.01 | December 2024 | 1 company | No decision yet | Not yet | Not yet | September 2038 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Tirbanibulin
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
One company has applied to the FDA to make generic tirbanibulin.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for this one yet, so the company is not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Klisyri’s patents with the FDA since December 2024: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic tirbanibulin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic tirbanibulin 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).
Klisyri 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 Klisyri, 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 Klisyri
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 Klisyri, before manufacturer rebates.
- $1.2M
- January to March 2026, the latest CMS has posted
For 723 people, about $1,423 per prescription fill - $4.6M
- 2025, the whole year
For 2,540 people, about $1,359 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $1,174,143 | 723 | $1,423.20 |
| 2025 | $4,645,214 | 2,540 | $1,358.65 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Klisyri only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a certain skin condition (actinic keratosis) on the face or scalp area.
Klisyri Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 1% | Ointment | Topical | December 2020 | Prescription reference product |
Source: FDA Orange Book, Almirall LLC. Listed for sale today by Almirall, LLC (FDA NDC Directory).
Klisyri NDC Codes and Packages
Each Klisyri 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 |
|---|---|---|---|
| 16110-0391-05 | TIRBANIBULIN 10 mg/g ointment | carton of 5 packets of .25 g | Almirall, LLC |
| 16110-0391-05 | TIRBANIBULIN 10 mg/g ointment | carton of 5 packets of .25 g | Almirall, LLC |
| 16110-0391-55 | TIRBANIBULIN 10 mg/g ointment | carton of 5 packets of .35 g | Almirall, LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Klisyri’s own FDA approval (NDA 213189) are listed, never a generic. Some codes belong to companies that repackage Klisyri: it is the same medicine in a different package.
What a Generic Klisyri Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Klisyri 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 Klisyri”. 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 Klisyri
Is there a generic for Klisyri right now?
No. As of October 9, 2026 no generic tirbanibulin is listed for sale in the FDA NDC Directory.
When will Klisyri go generic?
2035 to 2036 is the expected window, and that is probable but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to September 2038; a court ruling or a settlement can bring a generic sooner.
Will generic tirbanibulin be the same as Klisyri?
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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Klisyri?
Not yet. The FDA Orange Book lists no approved generic version of Klisyri.
When does the Klisyri patent expire?
The FDA Orange Book lists 7 patents for Klisyri; the last runs to September 2038. 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 window on this page (2035 to 2036) weighs all of that.
Has anyone challenged the Klisyri patents?
Yes. The first patent challenge to Klisyri reached the FDA in December 2024, from one company on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected 2035 to 2036 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
- Cuvrior BDTrientine TetrahydrochlorideApril 2029
- ValtocoDiazepam2030 to 2031
- Abilify AsimtufiiAripiprazoleApril 2033
- RezlidhiaOlutasidenib2037 to 2038
- MyqorzoAficamten2040 to 2041
- IcotydeIcotrokinraDuring 2041
About Klisyri
- Generic name tirbanibulin
- How it is taken On the skin
- Company Almirall LLC
- Patent challenges Since December 2024 (FDA)
- More drugs Brand-name drugs starting with K
- Have a question? A pharmacist answers, free. Ask about Klisyri
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, FDA Paragraph IV Patent Certifications list, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.