The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Exxua
gepirone · GEPIRONE HYDROCHLORIDE 18.2 mg/1 · Tablet, Extended Release · Oral · Aytu Therapeutics, LLC
NDC 23594-0150-30 · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE · NDA · View full market →
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ⓘ
$61.55per unit
middle half $60.65–$63.35 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
$36.93–$46.16
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 58% · step therapy 18% · qty limit 93%
*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 2 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
$60.73
Reported to Texas DSHS · 2026 annual filing · Aytu Therapeutics, LLC
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.0%chance of a new FDA shortage posting for gepirone (oral solid) in the next 90 days
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 →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier · median tier 5 across plans
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA021164
- TE code
- —
- Approval date
- Sep 22, 2023
- Patents / exclusivity
- 4 patents, 4 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NCE | Sep 22, 2028 |
| exclusivity | NCE | Sep 22, 2028 |
| exclusivity | NCE | Sep 22, 2028 |
| exclusivity | NCE | Sep 22, 2028 |
| patent | 7538116 | Sep 2, 2030 |
| patent | 7538116 | Sep 2, 2030 |
| patent | 7538116 | Sep 2, 2030 |
| patent | 7538116 | Sep 2, 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 gepirone (Tablet, Extended Release)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aytu Therapeutics, LLC | GEPIRONE HYDROCHLORIDE 18.2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aytu Therapeutics, LLC | GEPIRONE HYDROCHLORIDE 36.3 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aytu Therapeutics, LLC | GEPIRONE HYDROCHLORIDE 54.5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aytu Therapeutics, LLC | GEPIRONE HYDROCHLORIDE 72.6 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Exxua — NDC 23594-0150-30," retrieved September 3, 2026, https://drugdashboards.com/drug/23594015030.
Free to cite with attribution — see how the data is put together.