DrugDashboards

Palsonify

Paltusotine · PALTUSOTINE HYDROCHLORIDE 20 mg/1 · Tablet, Film Coated · Oral · Crinetics Pharmaceuticals, Inc.

NDC 84015-0920-60 · 60 TABLET, FILM COATED 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.

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
$384.37per unit
middle half $384.37$384.37 · 38 plans · Apr 1, 2026
Est. net of rebates
$230.62–$288.28
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 100%

*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
$24,165.00
Reported to Texas DSHS · 2026 annual filing · Crinetics Pharmaceuticals, 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 2 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
NDA219070
TE code
Approval date
Sep 25, 2025
Patents / exclusivity
18 patents, 4 exclusivities
TypeNumber / codeExpires
exclusivityODE-537Sep 25, 2032
exclusivityODE-537Sep 25, 2032
exclusivityNCESep 25, 2030
exclusivityNCESep 25, 2030
patent12208092Mar 25, 2044
patent12208092Mar 25, 2044
patent11266641Sep 7, 2041
patent11266641Sep 7, 2041
patent11957674Sep 7, 2041
patent11957674Sep 7, 2041
patent10464918Jan 16, 2039
patent10464918Jan 16, 2039

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Paltusotine (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Crinetics Pharmaceuticals, Inc.PALTUSOTINE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Crinetics Pharmaceuticals, Inc.PALTUSOTINE HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Palsonify — NDC 84015-0920-60," retrieved September 3, 2026, https://drugdashboards.com/drug/84015092060.

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