DrugDashboards

Isturisa

Osilodrostat · OSILODROSTAT PHOSPHATE 5 mg/1 · Tablet, Coated · Oral · Recordati Rare Diseases, Inc.

NDC 55292-0331-60 · 60 TABLET, COATED in 1 BLISTER PACK · 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)$249.21per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$1,313.14per unitnegotiated price across 226 plans — before rebates · Apr 1, 2026
  • List price (WAC, as filed)$77,154.56per packageRecordati Rare Disease, Inc. · Jan 9, 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
$1,313.14per unit
middle half $1,234.25$1,318.36 · 226 plans · Apr 1, 2026
Est. net of rebates
$787.88–$984.85
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
4%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 84%

*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
$59,578.81
Reported to Texas DSHS · 2026 annual filing · Recordati Rare Diseases, 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 3 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $28,687.53 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA212801
TE code
Approval date
Mar 6, 2020
Patents / exclusivity
18 patents, 6 exclusivities
TypeNumber / codeExpires
exclusivityODE-535Apr 15, 2032
exclusivityODE-535Apr 15, 2032
exclusivityODE-535Apr 15, 2032
exclusivityODE-286Mar 6, 2027
exclusivityODE-286Mar 6, 2027
exclusivityODE-286Mar 6, 2027
patent10709691Oct 12, 2035
patent10709691Oct 12, 2035
patent10709691Oct 12, 2035
patent10143680Jul 6, 2035
patent10143680Jul 6, 2035
patent10143680Jul 6, 2035

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Osilodrostat (Tablet, Coated)

LabelerStrengthFirst seenLast seen
Recordati Rare Diseases, Inc.OSILODROSTAT PHOSPHATE 1 mg/1Jul 15, 2026Sep 3, 2026
Recordati Rare Diseases, Inc.OSILODROSTAT PHOSPHATE 5 mg/1Jul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Isturisa — NDC 55292-0331-60," retrieved September 3, 2026, https://drugdashboards.com/drug/55292033160.

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