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.
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 →
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.
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.
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.
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.
*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.
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Not scored — fragility is computed for NADAC-priced NDCs.
There's no legal definition — it meets 3 of 6 public criteria. Why that matters →
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | ODE-519 | Feb 13, 2033 |
| exclusivity | ODE-519 | Feb 13, 2033 |
| exclusivity | ODE-489 | Jun 21, 2031 |
| exclusivity | ODE-489 | Jun 21, 2031 |
| exclusivity | ODE-331 | Oct 13, 2027 |
| exclusivity | ODE-331 | Oct 13, 2027 |
| exclusivity | NPP | Jun 21, 2027 |
| exclusivity | NPP | Jun 21, 2027 |
| exclusivity | ODE-255 | Aug 14, 2026 |
| exclusivity | ODE-255 | Aug 14, 2026 |
| patent | 8207197 | Mar 7, 2030 |
| patent | 8207197 | Mar 7, 2030 |
No FDA shortage reports for this drug or its presentations.
No enforcement reports list this package NDC.
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Harmony Biosciences, LLC | PITOLISANT HYDROCHLORIDE 17.8 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Harmony Biosciences, LLC | PITOLISANT HYDROCHLORIDE 4.45 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Patheon France S.A.S | PITOLISANT HYDROCHLORIDE 17.8 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Patheon France S.A.S | PITOLISANT HYDROCHLORIDE 4.45 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Patheon Pharmaceuticals Inc. | PITOLISANT HYDROCHLORIDE 4.45 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
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.