DrugDashboards

Leqselvi

deuruxolitinib phosphate · DEURUXOLITINIB PHOSPHATE 8 mg/1 · Tablet, Film Coated · Oral · Sun Pharmaceutical Industries, Inc.

NDC 47335-0108-86 · 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC · 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.

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
$75.43per unit
middle half $75.13$76.19 · 171 plans · Apr 1, 2026
Est. net of rebates
$45.26–$56.57
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
3%of plans cover it
tier 5 · prior auth 42% · step therapy 0% · qty limit 33%

*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 3 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
$4,563.71
Reported to Texas DSHS · 2026 annual filing · Sun Pharmaceutical Industries, Inc.

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

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

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
NDA217900
TE code
Approval date
Jul 25, 2024
Patents / exclusivity
6 patents, 1 exclusivities
TypeNumber / codeExpires
exclusivityNCEJul 25, 2029
patent12364699Oct 10, 2044
patent12247034May 10, 2044
patent12285432Aug 11, 2042
patent11919907May 21, 2041
patent10561659May 4, 2037
patent12076323May 4, 2037

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of deuruxolitinib phosphate (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Sun Pharmaceutical Industries, Inc.DEURUXOLITINIB PHOSPHATE 8 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Leqselvi — NDC 47335-0108-86," retrieved September 3, 2026, https://drugdashboards.com/drug/47335010886.

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