DrugDashboards

Koselugo

Selumetinib · SELUMETINIB 25 mg/1 · Capsule · Oral · AstraZeneca Pharmaceuticals LP

NDC 00310-0625-28 · 28 CAPSULE in 1 BOTTLE · 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)$182.85per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal ceiling (Big4)$176.86per unitASTRAZENECA PHARMACEUTICALS LP · Jan 1, 2026
  • List price (WAC, as filed)$5,896.16per packageAlexion · Oct 1, 2022

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00310-0625-60) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ 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
$249.76per unit
middle half $237.57$255.30 · 5,496 plans · Apr 1, 2026
Est. net of rebates
$149.85–$187.32
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 98% · step therapy 0% · qty limit 65%

*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
$6,968.64
Reported to Texas DSHS · 2026 annual filing · Alexion

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

Medicaid spend (2025)

$82,147
11 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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $19,031.24 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA213756
TE code
Approval date
Apr 10, 2020
Patents / exclusivity
16 patents, 6 exclusivities
TypeNumber / codeExpires
exclusivityODE-545Nov 19, 2032
exclusivityODE-545Nov 19, 2032
exclusivityNPPNov 19, 2028
exclusivityNPPNov 19, 2028
exclusivityODE-288Apr 10, 2027
exclusivityODE-288Apr 10, 2027
patent12220403Mar 26, 2029
patent12364684Mar 26, 2029
patent12364684Mar 26, 2029
patent11813246Mar 26, 2029
patent11813246Mar 26, 2029
patent12318367Mar 26, 2029

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Selumetinib (Capsule)

LabelerStrengthFirst seenLast seen
AstraZeneca ABSELUMETINIB 5 mg/1Jul 15, 2026Sep 2, 2026
AstraZeneca ABSELUMETINIB 7.5 mg/1Jul 15, 2026Sep 2, 2026
AstraZeneca Pharmaceuticals LPSELUMETINIB 10 mg/1Jul 15, 2026Sep 2, 2026
AstraZeneca Pharmaceuticals LPSELUMETINIB 25 mg/1Jul 15, 2026Sep 2, 2026
Patheon Pharmaceuticals Inc.SELUMETINIB 10 mg/1Jul 15, 2026Sep 2, 2026
Patheon Pharmaceuticals Inc.SELUMETINIB 25 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Koselugo — NDC 00310-0625-28," retrieved September 3, 2026, https://drugdashboards.com/drug/00310062528.

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