DrugDashboards

Exxua

gepirone · GEPIRONE HYDROCHLORIDE 72.6 mg/1 · Tablet, Extended Release · Oral · Aytu Therapeutics, LLC

NDC 23594-0153-30 · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE · NDA · View full market →

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.

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 point of sale (median)$61.55per unitnegotiated price across 5,496 plans — before rebates · Apr 1, 2026
  • Federal contracts pay (FSS)$45.46per unitNeos Therapeutics Brands · Feb 25, 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
$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 95%

*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
TypeNumber / codeExpires
exclusivityNCESep 22, 2028
exclusivityNCESep 22, 2028
exclusivityNCESep 22, 2028
exclusivityNCESep 22, 2028
patent7538116Sep 2, 2030
patent7538116Sep 2, 2030
patent7538116Sep 2, 2030
patent7538116Sep 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)

LabelerStrengthFirst seenLast seen
Aytu Therapeutics, LLCGEPIRONE HYDROCHLORIDE 18.2 mg/1Jul 15, 2026Sep 2, 2026
Aytu Therapeutics, LLCGEPIRONE HYDROCHLORIDE 36.3 mg/1Jul 15, 2026Sep 2, 2026
Aytu Therapeutics, LLCGEPIRONE HYDROCHLORIDE 54.5 mg/1Jul 15, 2026Sep 2, 2026
Aytu Therapeutics, LLCGEPIRONE HYDROCHLORIDE 72.6 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Exxua — NDC 23594-0153-30," retrieved September 3, 2026, https://drugdashboards.com/drug/23594015330.

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