DrugDashboards

Wainua

Eplontersen · EPLONTERSEN 45 mg/.8mL · Injection, Solution · Subcutaneous · AstraZeneca Pharmaceuticals LP

NDC 00310-9400-01 · 1 SYRINGE, GLASS in 1 CARTON / .8 mL in 1 SYRINGE, GLASS · 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 plans paid (avg)$52,214.29per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$51,621.86per unitnegotiated price across 48 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$32,146.83per package of 0.8MLASTRAZENECA PHARMACEUTICALS LP · 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
$51,621.86per unit
middle half $51,415.45$55,274.82 · 48 plans · Apr 1, 2026
Est. net of rebates
$30,973.12–$38,716.40
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
1%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 52%

*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 9 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
$42,830.83
Reported to Texas DSHS · 2026 annual filing · AstraZeneca

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

Medicaid spend (2025)

$3.2M
75 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 4 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $42,720.78 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA217388
TE code
Approval date
Dec 21, 2023
Patents / exclusivity
7 patents, 2 exclusivities
TypeNumber / codeExpires
exclusivityODE-461Dec 21, 2030
exclusivityNCEDec 21, 2028
patent10683499Aug 25, 2034
patent10683499Aug 25, 2034
patent9181549May 1, 2034
patent9127276May 1, 2034
patent9181549May 1, 2034
patent9127276May 1, 2034
patent8101743Apr 1, 2026

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Eplontersen (Injection, Solution)

LabelerStrengthFirst seenLast seen
AstraZeneca Pharmaceuticals LPEPLONTERSEN 45 mg/.8mLJul 15, 2026Sep 3, 2026

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

Cite this page

DrugDashboards, "Wainua — NDC 00310-9400-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00310940001.

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