Prescription medicine
Trifarotene Brand names: Aklief
Trifarotene (Aklief) is a prescription medicine with an FDA approval on record since 2019. No generic is listed; pharmacies paid $16.36 per gram (Aklief 0.005% cream) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the trifarotene FDA label on DailyMed (effective September 16, 2024, Galderma Laboratories, L.P.); the NDA 211527 record on Drugs@FDA; every trifarotene label on DailyMed.
Highlights of the record
FDA label of September 16, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Forms and strengths
Cream.
On the market
- Earliest approval on file
- October 4, 2019 Aklief, Galderma Labs Lp; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- May 30, 2033 Aklief cream; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $16.36 per gram Aklief 0.005% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 180 through July 30, 2026
What is trifarotene used for?
From the label: indications and usageAKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Conditions named in the indications of trifarotene's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Retinoid.
Source: FDA drug label (AKLIEF), Galderma Laboratories, L.P., effective September 16, 2024 (SPL set 62d910db-85a6-4696-b69b-4bd2f3080cfc), via openFDA; the full label on DailyMed
Is there a generic for trifarotene (Aklief)?
No generic trifarotene is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Aklief cream: the compound patent runs to July 19, 2031, and the last listed entry to May 30, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for trifarotene (Aklief)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $16.36 per gram (Aklief 0.005% cream), up 4% from $15.71 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Aklief 0.005% cream (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Aklief 0.005% cream | Brand | $16.36 per gram | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the trifarotene label say about other medicines?
The trifarotene label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Levonorgestrel | drug interactions | DRUG INTERACTIONS Topical application of AKLIEF Cream is not expected to affect the circulating concentrations of oral hormonal contraceptives containing ethinyl estradiol and levonorgestrel. |
Source: FDA drug label (AKLIEF), Galderma Laboratories, L.P., effective September 16, 2024 (SPL set 62d910db-85a6-4696-b69b-4bd2f3080cfc), via openFDA; the full label on DailyMed
What do FAERS reports show for trifarotene?
The FDA Adverse Event Reporting System holds 180 reports that list trifarotene among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 9 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 trifarotene?
15 other medicines are given the same way (topical) and in the same FDA class as trifarotene or labeled mainly for the same use (acne), the same class first. Acne lists all 26 medicines labeled for it, by any route. The first 8 are below. 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 |
|---|---|---|---|---|
| Tretinoin | Acne | 19 labelers | $0.506 per gram 0.025% cream | No current entry |
| Adapalene | Acne | 34 labelers | $0.504 per gram 0.3% gel | No current entry |
| Adapalene and benzoyl peroxide | Acne | 11 labelers | $0.626 per gram 0.3-2.5% | No current entry |
| Tazarotene | Acne | 6 labelers | $6.11 per gram 0.1% gel | No current entry |
| Clindamycin and tretinoin | Acne | 3 labelers | $3.91 per gram 1.2%-0.025% | No current entry |
| Benzoyl peroxide and tretinoin | Acne | none listed | $31.66 per gram 0.1%-3% cream pump | No current entry |
| Adapalene and benzoyl peroxide and clindamycin | Acne | none listed | n/a | No current entry |
| Salicylic acid | Acne | none listed | $0.102 per patch Callus removers patch | No current entry |
Every medicine labeled for the same conditions as trifarotene
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to trifarotene
- 15 medicines for the same use
- Other retinoids
- the pharmacologic class, with prices and generics
- Trifarotene side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other