Duobrii Generic: When Will It 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
Duobrii Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2034 to 2035 A wide window Why then?
- Has the FDA approved a generic? May 2025 1 company approved Why not on sale?
- When does the last patent end? June 2036 10 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 halobetasol propionate and tazarotene is expected to be available between 2034 and 2035. None is for sale yet.
Why 2034 to 2035?
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 Duobrii’s last patent runs to June 2036, how can a generic come sooner?
The 4 patents that run past the expected month, to June 2036 (10,251,895, 10,426,787, 11,648,256 and 11,679,115), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, a settlement between the companies sets the date. Generic companies have been challenging Duobrii’s patents with the FDA since June 2020. That is why the expected month comes before the last protection ends. See the road to a generic
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. One company has held an approval since May 2025, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 2 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic, which would take the $10.00 pharmacies pay per gram for Duobrii today to about $5.60. See the price estimate
What should I do now?
Keep taking Duobrii 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.
Duobrii 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
- Moderate 2 companies have filed, 1 first in line
- Brand sales
- $8M a yearSmaller seller
- FDA approved 2019 April 2019 FDA Orange Book
- Patents listed 10 last runs to June 2036 A generic is expected sooner, between 2034 and 2035. See why FDA Orange Book
- Generics FDA-approved 1 company, approved May 2025 FDA Orange Book
- Pharmacies pay $10.00 per gram NADAC, February 2024
- Medicare Part D spent $531.7K in 2025, for 316 people CMS Part D Spending by Drug
- Medicaid prescriptions 191 in the last four reported quarters, $191.3K CMS Medicaid drug utilization, to Q3 2025
Duobrii’s Road to a Generic
Duobrii has had the market to itself since the FDA approved it in April 2019 (Bausch Health Americas Inc). Its 10 listed patents run to June 2036. Generic companies have challenged its patents with the FDA since June 2020.
The first generic of Duobrii is expected between 2034 and 2035.
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 June 2036
The last listed patent runs to June 2036, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. 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.
Duobrii Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Duobrii’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 |
|---|---|---|---|
| 8,809,307 | The product’s formulation | November 2031 | Active |
| 10,478,502 | The product’s formulation; a way of using it (U-2625) | November 2031 | Active |
| 11,839,656 | A way of using it (U-2625) | November 2031 | Active |
| 11,957,753 | The product’s formulation | November 2031 | Active |
| 11,986,527 | A way of using it (U-2625) | November 2031 | Active |
| 12,076,403 | The product’s formulation | November 2031 | Active |
| 10,251,895 | The product’s formulation | June 2036 | Active |
| 10,426,787 | A way of using it (U-2625) | June 2036 | Active |
| 11,648,256 | The product’s formulation; a way of using it (U-2625) | June 2036 | Active |
| 11,679,115 | The product’s formulation; a way of using it (U-2625) | June 2036 | Active |
Source: FDA Orange Book, application 209354. Patent numbers open the patent on Google Patents.
Patent Challenges to Duobrii
The first patent challenge to Duobrii reached the FDA in June 2020, 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 Duobrii’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 | |||||
| Lotion, 0.01%/0.045% | June 2020 | 1 company | Head start no longer applies decided February 2025 | Not yet | Not yet | June 2036 |
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 Halobetasol Propionate and Tazarotene
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
2 companies have applied to the FDA to make generic halobetasol propionate and tazarotene.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
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 Duobrii’s patents with the FDA since June 2020: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in May 2025. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Not yet. No company lists a generic halobetasol propionate and tazarotene for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Sun Pharma Canada Inc | May 2025 | 0.01%;0.045% | AB |
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).
Duobrii Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Duobrii today: $10.00 per gram for Duobrii 0.01%-0.045% lotion in February 2024, 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). Duobrii has 2 companies lined up, so our estimate uses the figure for two companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $10.00 pharmacies pay per gram 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 Duobrii
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 Duobrii, before manufacturer rebates.
- $104K
- January to March 2026, the latest CMS has posted
For 87 people, about $1,061 per prescription fill - $531.7K
- 2025, the whole year
For 316 people, about $1,019 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $103,969 | 87 | $1,060.91 |
| 2025 | $531,692 | 316 | $1,018.57 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Duobrii only, so no generic is counted in it. What CMS says it is used for: This medication is a combination product used to treat a certain skin condition (psoriasis). It contains 2 ingredients: halobetasol and tazarotene.
Medicaid Prescriptions by Quarter
191 prescriptions in the four quarters to Q3 2025, $191.3K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q3 2025 | 45 | $45,642 |
| Q2 2025 | 64 | $64,399 |
| Q1 2025 | 82 | $81,249 |
Source: CMS Medicaid State Drug Utilization Data, over Duobrii’s own package codes.
Duobrii Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.01%;0.045% | Lotion | Topical | April 2019 | Prescription reference product |
Source: FDA Orange Book, Bausch Health Americas Inc. Listed for sale today by Bausch Health US, LLC (FDA NDC Directory).
Duobrii NDC Codes and Packages
Each Duobrii 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 |
|---|---|---|---|
| 00187-0653-01 | HALOBETASOL PROPIONATE .1 mg/g / TAZAROTENE .45 mg/g lotion | tube of 100 g | Bausch Health US, LLC |
| 00187-0653-01 | HALOBETASOL PROPIONATE .1 mg/g / TAZAROTENE .45 mg/g lotion | tube of 100 g | Bausch Health US, LLC |
| 00187-0653-03 | HALOBETASOL PROPIONATE .1 mg/g / TAZAROTENE .45 mg/g lotion | carton of 6 tubes of 3 g | Bausch Health US, LLC |
| 00187-0653-03 | HALOBETASOL PROPIONATE .1 mg/g / TAZAROTENE .45 mg/g lotion | carton of 6 tubes of 3 g | Bausch Health US, LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Duobrii’s own FDA approval (NDA 209354) are listed, never a generic. Some codes belong to companies that repackage Duobrii: it is the same medicine in a different package.
What a Generic Duobrii Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Duobrii 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 Duobrii”. 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 Duobrii
Is there a generic for Duobrii right now?
No. As of October 9, 2026 no generic halobetasol propionate and tazarotene is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Duobrii go generic?
2034 to 2035 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 June 2036, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic halobetasol propionate and tazarotene be the same as Duobrii?
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. 2 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic, which would take the $10.00 pharmacies pay per gram for Duobrii today to about $5.60. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Duobrii?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in May 2025: Sun Pharma Canada Inc. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Duobrii patent expire?
The FDA Orange Book lists 10 patents for Duobrii; the last runs to June 2036. 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 (2034 to 2035) weighs all of that.
Has anyone challenged the Duobrii patents?
Yes. The first patent challenge to Duobrii reached the FDA in June 2020, 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.
How much does Duobrii cost now?
Pharmacies paid about $10.00 per gram for Duobrii 0.01%-0.045% lotion in February 2024, 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 2034 to 2035 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
- PromactaEltrombopag OlamineDuring 2026
- LumifyBrimonidine TartrateJune 2027
- FuroscixFurosemideApril 2034
- BysantiMilsaperidone2036 to 2037
- ZegfrovySunvozertinibJuly 2039
- TreandaBendamustine HydrochlorideTBD no date yet
About Duobrii
- Generic name halobetasol propionate and tazarotene
- How it is taken On the skin
- Company Bausch Health Americas Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since June 2020 (FDA)
- More drugs Brand-name drugs starting with D
- Have a question? A pharmacist answers, free. Ask about Duobrii
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, 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.