Picato Generic: When Will Generic Ingenol Mebutate 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
Picato Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? January 2019 Since discontinued
- When does the last patent end? May 2033 12 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
There is no expected month yet for generic ingenol mebutate. None is for sale yet.
Will the generic cost less?
Usually, and more so as more companies sell one. 4 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. See the price pattern
What should I do now?
Keep taking Picato 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.
Picato 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
- Strong 4 companies have filed, 4 first in line
- Brand sales
- Sales not reported
- FDA approved 2012 January 2012 FDA Orange Book
- Patents listed 12 last runs to May 2033 FDA Orange Book
Picato’s Road to a Generic
Picato has had the market to itself since the FDA approved it in January 2012 (Leo Laboratories Ltd). Its 12 listed patents run to May 2033. Generic companies have challenged its patents with the FDA since January 2016.
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
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.
Picato Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Picato’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 |
|---|---|---|---|
| 8,372,827 | The product’s formulation | December 2026 | Active |
| 8,372,828 | The product’s formulation | December 2026 | Active |
| 8,377,919 | The product’s formulation | December 2026 | Active |
| 8,536,163 | A way of using it (U-1440) | December 2026 | Active |
| 8,716,271 | A way of using it (U-1440) | December 2026 | Active |
| 8,735,375 | A way of using it (U-1440) | December 2026 | Active |
| 9,820,959 | The product’s formulation; a way of using it (U-1440) | December 2026 | Active |
| 9,833,428 | The product’s formulation | December 2026 | Active |
| 9,833,429 | The product’s formulation | December 2026 | Active |
| 9,861,603 | A way of using it (U-1440) | December 2026 | Active |
| 8,278,292 | The product’s formulation | July 2027 | Active |
| 9,789,078 | A way of using it (U-2138) | May 2033 | Active |
Source: FDA Orange Book, application 202833. Patent numbers open the patent on Google Patents.
Patent Challenges to Picato
The first patent challenge to Picato reached the FDA in January 2016, from 2 companies on that first day. The FDA’s list has 2 entries for Picato, by form and strength. The FDA approved a first challenger’s generic in January 2019, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Picato’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 | |||||
| Gel, 0.00015 | January 2016 | 2 companies | First challenger eligible decided August 2019 | January 2019 | Not yet | July 2027 |
| Gel, 0.0005 | January 2016 | 2 companies | First challenger eligible decided August 2019 | January 2019 | Not yet | July 2027 |
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 Ingenol Mebutate
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
4 companies have applied to the FDA to make generic ingenol mebutate.
The FDA has tentatively approved one company’s generic: Actavis Labs (February 2018). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 4 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Picato’s patents with the FDA since January 2016: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic ingenol mebutate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic ingenol mebutate for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Padagis Israel Pharmaceuticals Ltd discontinued | January 2019 | 0.015%, 0.05% | – |
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).
Picato 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 Picato, 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.
Picato Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.015% | Gel | Topical | January 2012 | Discontinued reference product |
| 0.05% | Gel | Topical | January 2012 | Discontinued reference product |
Source: FDA Orange Book, Leo Laboratories Ltd.
What a Generic Picato Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Picato 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 Picato”. 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 Picato
Is there a generic for Picato right now?
No. As of October 9, 2026 no generic ingenol mebutate is listed for sale in the FDA NDC Directory. 2 generic versions are FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Picato go generic?
There is no expected month yet. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Will generic ingenol mebutate be the same as Picato?
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. 4 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Picato?
Not yet. The FDA Orange Book lists no approved generic version of Picato that is still marketed.
When does the Picato patent expire?
The FDA Orange Book lists 12 patents for Picato; the last runs to May 2033. 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 (a date that is not known yet) weighs all of that.
Has anyone challenged the Picato patents?
Yes. The first patent challenge to Picato reached the FDA in January 2016, from 2 companies on that first day. The FDA approved a first challenger’s generic in January 2019, and the list records no sale by a first challenger 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 a date that is not known yet 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
- InrebicFedratinib Hydrochloride2033 to 2034
- Alkindi SprinkleHydrocortisoneJanuary 2033
- DificidFidaxomicinNovember 2034
- VevyeCyclosporineSeptember 2037
- Norepinephrine Bitartrate in Sodium ChlorideNorepinephrine BitartrateJanuary 2038
- RyzumviPhentolamine MesylateOctober 2039
About Picato
- Generic name ingenol mebutate
- How it is taken On the skin
- Company Leo Laboratories Ltd
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since January 2016 (FDA)
- More drugs Brand-name drugs starting with P
- Have a question? A pharmacist answers, free. Ask about Picato
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.