Prescription medicine

Clascoterone Brand names: Winlevi

Clascoterone (Winlevi) is a prescription medicine with an FDA approval on record since 2020. No generic is listed; pharmacies paid $10.00 per gram (Winlevi 1% cream) in the October 7, 2026 NADAC survey.

No generic listed

Check it at the source: the clascoterone FDA label on DailyMed (effective January 2, 2025, Sun Pharmaceutical Industries, Inc.); the NDA 213433 record on Drugs@FDA; every clascoterone label on DailyMed.

Highlights of the record

FDA label of January 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Forms and strengths

1 g/100g

Cream.

On the market

Earliest approval on file: August 26, 2020 Winlevi, Sun Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing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: July 25, 2030 Winlevi cream; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $10.00 per gram Winlevi 1% cream
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 1,418 through July 30, 2026

What is clascoterone used for?

From the label: indications and usage
WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Conditions named in the indications of clascoterone's FDA labels, with every medicine labeled for each:

Acne

FDA pharmacologic class: Androgen Receptor Inhibitor.

Source: FDA drug label (Winlevi), Sun Pharmaceutical Industries, Inc., effective January 2, 2025 (SPL set 1673a84b-7f5c-47ab-a99c-1e3db21a6a09), via openFDA; the full label on DailyMed

What does the patient leaflet for clascoterone say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while using WINLEVI cream?
Avoid using WINLEVI cream on skin areas with cuts, abrasions, eczema, or on sunburned skin. Avoid getting WINLEVI cream into your eyes, lips, mouth, corners of the nose, or mucous membranes. If contact with mucous membranes happens, rinse well with water. Avoid using skin products that may dry or irritate your skin such as: medicated or abrasive soaps and cleansers soaps, cleansers, and cosmetics that have strong skin drying effects products that contain high amounts of alcohol astringents, spices, or lime

From the patient leaflet: How should I store WINLEVI cream?
Store WINLEVI cream at room temperature between 68°F and 77°F (20°C to 25°C). Do not freeze. Throw away (discard) the unused portion 180 days after the date of dispensing or 1 month after first opening, whichever is sooner. Keep WINLEVI cream and all medicines out of the reach of children. General Information about the safe and effective use of WINLEVI cream. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use WINLEVI cream for a condition for which it was not prescribed. Do not give WINLEVI cream to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about WINLEVI cream that is written for health professionals.

Source: FDA drug label (Winlevi), Sun Pharmaceutical Industries, Inc., effective January 2, 2025 (SPL set 1673a84b-7f5c-47ab-a99c-1e3db21a6a09), via openFDA; the full label on DailyMed

Is there a generic for clascoterone (Winlevi)?

No generic clascoterone is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 8 patents for Winlevi cream, the last expiring on July 25, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2020 earliest approval on file
2030 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for clascoterone (Winlevi)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $10.00 per gram (Winlevi 1% cream), up 2% from $9.80 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.

Winlevi 1% cream (brand)

$10.00

$9.31

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Winlevi 1% cream	Brand	$10.00 per gram	n/a	+2%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What do FAERS reports show for clascoterone?

The FDA Adverse Event Reporting System holds 1,418 reports that list clascoterone 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 6 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.

Reports received each year

The most reported reactions

Product Storage Error333
Product Physical Consistency Issue329
Product Use Complaint (a use or a product term, not a reaction)286
Product Dose Omission Issue (a use or a product term, not a reaction)184
Product Use Issue (a use or a product term, not a reaction)153
Drug Ineffective (a use or a product term, not a reaction)146
Therapy Cessation86
Poor Quality Product Administered84

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as clascoterone?

14 other medicines are given the same way (topical) and in the same FDA class as clascoterone 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
Salicylic acid	Acne	none listed	$0.102 per patch Callus removers patch	No current entry
Benzoyl peroxide	Acne	none listed	$0.0469 per gram 10% wash	No current entry
Sulfur	Acne	none listed	n/a	No current entry
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
Benzoyl peroxide and clindamycin	Acne	11 labelers	$0.622 per gram 1-5%	No current entry
Dapsone	Acne	16 labelers	$0.664 per gram 5% gel	A presentation being discontinued
Adapalene and benzoyl peroxide	Acne	11 labelers	$0.626 per gram 0.3-2.5%	No current entry

Every medicine labeled for the same conditions as clascoterone

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to clascoterone: 14 medicines for the same use
Other androgen receptor inhibitors: the pharmacologic class, with prices and generics
Clascoterone side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other