DrugDashboards

Rytelo

imetelstat sodium · IMETELSTAT SODIUM 47 mg/1 · Injection, Powder, Lyophilized, For Solution · Intravenous · Geron Corporation

NDC 82959-0112-01 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE · 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.

  • Medicare Part B pays (ASP+6%)$59.53per billing unit (1 MG)HCPCS J0870 · Jul 1, 2026
  • Part D plans paid (avg)$3,704.76per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal ceiling (Big4)$1,902.50per unitGeron Corp · Jan 1, 2026

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

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
$2,602.40
Reported to Texas DSHS · 2026 annual filing · Geron Corporation

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

Medicare Part B (ASP)

Payment limit per 1 MG
$59.531
HCPCS J0870 · Jul 1, 2026 quarter · typically ASP + 6%

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
  • Costs ≥ $950/fill · avg $31,415.18 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA217779
TE code
Approval date
Jun 6, 2024
Patents / exclusivity
12 patents, 2 exclusivities
TypeNumber / codeExpires
exclusivityODE-482Jun 6, 2031
exclusivityODE-482Jun 6, 2031
patent12171778Jun 16, 2039
patent12171778Jun 16, 2039
patent9375485Mar 15, 2033
patent12442000Mar 15, 2033
patent9375485Mar 15, 2033
patent12442000Mar 15, 2033
patent7494982Dec 27, 2026
patent7494982Dec 27, 2026
patent9388415Sep 9, 2026
patent9388415Sep 9, 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 imetelstat sodium (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
Catalent Indiana, LLCIMETELSTAT SODIUM 188 mg/1Jul 15, 2026Sep 2, 2026
Geron CorporationIMETELSTAT SODIUM 188 mg/1Jul 15, 2026Sep 2, 2026
Geron CorporationIMETELSTAT SODIUM 47 mg/1Jul 15, 2026Sep 2, 2026
Patheon Italia S.p.A.IMETELSTAT SODIUM 47 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Rytelo — NDC 82959-0112-01," retrieved September 3, 2026, https://drugdashboards.com/drug/82959011201.

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