DrugDashboards

Wakix

Pitolisant Hydrochloride · PITOLISANT HYDROCHLORIDE 17.8 mg/1 · Tablet, Film Coated · Oral · Harmony Biosciences, LLC

NDC 72028-0178-03 · 1 BOTTLE, PLASTIC in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC · NDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately.

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.

  • Part D plans paid (avg)$248.34per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$298.26per unitnegotiated price across 146 plans — before rebates · Apr 1, 2026
  • List price (WAC, as filed)$8,919.91per packageHarmony Biosciences, LLC · Jan 1, 2026

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
$298.26per unit
middle half $295.86$301.14 · 146 plans · Apr 1, 2026
Est. net of rebates
$178.95–$223.69
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
3%of plans cover it
tier 5 · prior auth 32% · step therapy 0% · qty limit 21%

*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 10 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Estimated fill cost

WAC per package, as filed
$8,336.36
Reported to Texas DSHS · 2026 annual filing · Harmony Biosciences

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

Medicaid spend (2025)

$126.4M
9,840 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Is this a "specialty" drug?

There's no legal definition — it meets 3 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $12,500.61 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA211150
TE code
AB
Approval date
Aug 14, 2019
Patents / exclusivity
6 patents, 10 exclusivities
TypeNumber / codeExpires
exclusivityODE-519Feb 13, 2033
exclusivityODE-519Feb 13, 2033
exclusivityODE-489Jun 21, 2031
exclusivityODE-489Jun 21, 2031
exclusivityODE-331Oct 13, 2027
exclusivityODE-331Oct 13, 2027
exclusivityNPPJun 21, 2027
exclusivityNPPJun 21, 2027
exclusivityODE-255Aug 14, 2026
exclusivityODE-255Aug 14, 2026
patent8207197Mar 7, 2030
patent8207197Mar 7, 2030

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Pitolisant Hydrochloride (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Harmony Biosciences, LLCPITOLISANT HYDROCHLORIDE 17.8 mg/1Jul 15, 2026Sep 2, 2026
Harmony Biosciences, LLCPITOLISANT HYDROCHLORIDE 4.45 mg/1Jul 15, 2026Sep 2, 2026
Patheon France S.A.SPITOLISANT HYDROCHLORIDE 17.8 mg/1Jul 15, 2026Sep 2, 2026
Patheon France S.A.SPITOLISANT HYDROCHLORIDE 4.45 mg/1Jul 15, 2026Sep 2, 2026
Patheon Pharmaceuticals Inc.PITOLISANT HYDROCHLORIDE 4.45 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Wakix — NDC 72028-0178-03," retrieved September 3, 2026, https://drugdashboards.com/drug/72028017803.

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