DrugDashboards

Winlevi

Clascoterone · CLASCOTERONE 1 g/100g · Cream · Topical · Sun Pharmaceutical Industries, Inc.

NDC 47335-0994-36 · 1 TUBE in 1 CARTON / 60 g in 1 TUBE · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price has held steady around $9.99 per gram over the past year. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$9.99per GMinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$9.64per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$10.01per unitnegotiated price across 4 plans — before rebates · Jul 1, 2025

Medicare Part D

All Part D pricing →
ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$10.01per unit
middle half $10.01$10.01 · 4 plans · Jul 1, 2025
Est. net of rebates
$6.00–$7.51
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
of plans cover it

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 7 quarters since 2024.

NADAC price per unit

$0$5.00$10.00Mar 2022Sep 2026$9.99
26 price points · per GMSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$614.24
Reported to Texas DSHS · 2026 annual filing · Sun Pharma

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2025)

$20.5M
35,106 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for clascoterone (other) in the next 90 days

sole-source market · price up 2% YoY

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
NDA213433
TE code
Approval date
Aug 26, 2020
Patents / exclusivity
8 patents, 0 exclusivities
TypeNumber / codeExpires
patent8785427Jul 25, 2030
patent9433628Feb 28, 2029
patent11207332Nov 20, 2028
patent10159682Aug 14, 2028
patent9486458Jul 24, 2028
patent12337002Jul 24, 2028
patent11938141Jul 24, 2028
patent8143240Jan 12, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Clascoterone (Cream)

LabelerStrengthFirst seenLast seen
Sun Pharmaceutical Industries, Inc.CLASCOTERONE 1 g/100gJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Winlevi — NDC 47335-0994-36," retrieved September 3, 2026, https://drugdashboards.com/drug/47335099436.

Free to cite with attribution — see how the data is put together.