Prescription medicine
Difamilast Brand names: Adquey
Difamilast (Adquey) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the difamilast FDA label on DailyMed (effective February 25, 2026, Acrotech Biopharma Inc); the NDA 219474 record on Drugs@FDA; every difamilast label on DailyMed.
Highlights of the record
FDA label of February 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageADQUEY is indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis.
Forms and strengths
- 10 mg/g
Ointment.
On the market
- Earliest approval on file
- February 12, 2026 Adquey, Acrotech Biopharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 31, 2036 Adquey ointment; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3 through July 30, 2026
What is difamilast used for?
From the label: indications and usageADQUEY is indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis. ADQUEY is a phosphodiesterase 4 inhibitor indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis.
Conditions named in the indications of difamilast's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Phosphodiesterase 4 Inhibitor.
Source: FDA drug label (ADQUEY), Acrotech Biopharma Inc, effective February 25, 2026 (SPL set 46c95e41-fa29-4e11-9d94-0fd4f0291c34), via openFDA; the full label on DailyMed
Is there a generic for difamilast (Adquey)?
No generic difamilast is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Adquey ointment: the compound patent runs to December 31, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2026 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for difamilast?
The FDA Adverse Event Reporting System holds 3 reports that list difamilast among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as difamilast?
7 other medicines are given the same way (topical) and in the same FDA class as difamilast or labeled mainly for the same use (eczema (atopic dermatitis)), the same class first. Eczema (atopic dermatitis) lists all 26 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Roflumilast | Eczema (atopic dermatitis) | none listed | $15.38 per gram 0.3% foam | No current entry |
| Crisaborole | Eczema (atopic dermatitis) | none listed | $11.68 per gram 2% ointment | No current entry |
| Oatmeal | Eczema (atopic dermatitis) | none listed | n/a | No current entry |
| Desonide | Eczema (atopic dermatitis) | 12 labelers | $0.252 per gram 0.05% cream | No current entry |
| Pimecrolimus | Eczema (atopic dermatitis) | 2 labelers | $3.31 per gram 1% cream | No current entry |
| Delgocitinib | Eczema (atopic dermatitis) | none listed | n/a | No current entry |
| Ruxolitinib | Eczema (atopic dermatitis) | none listed | $34.01 per gram 1.5% cream | No current entry |
Every medicine labeled for the same conditions as difamilast
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to difamilast
- 7 medicines for the same use
- Other phosphodiesterase 4 inhibitors
- the pharmacologic class, with prices and generics
- Difamilast side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other