DrugDashboards

Bildyos

Denosumab · DENOSUMAB 60 mg/mL · Injection, Solution · Subcutaneous · Organon LLC

NDC 78206-0193-01 · 1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS · BLA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want. Historically, drugs in this position went on to a new shortage within 90 days about 0.4% of the time — roughly 3× the typical drug (0.1%).

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.

  • Pharmacies pay (NADAC)$812.84per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicare Part B pays (ASP+6%)$15.66per billing unit (1 MG)HCPCS Q5162 · Jul 1, 2026
  • Part D plans paid (avg)$1,711.38per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$862.25per unitnegotiated price across 1,472 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$573.84per package of 1MLOrganon LLC · Mar 2, 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
$862.25per unit
middle half $856.46$880.68 · 1,472 plans · Apr 1, 2026
Est. net of rebates
$517.35–$646.68
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
27%of plans cover it
tier 4 · prior auth 5% · step therapy 0% · qty limit 98%

*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

$0$500.00$1000.00May 2026Sep 2026$812.84
4 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$844.00
Reported to Texas DSHS · 2026 annual filing · Organon LLC

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

Medicare Part B (ASP)

Payment limit per 1 MG
$15.660
HCPCS Q5162 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2026 YTD · Q1)

$72,266
83 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

20Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 3 active manufacturers+10
  • sterile injectable+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for denosumab (injectable) in the next 90 days

sterile injectable · sole-source market · price up 3% YoY

For scale: the typical drug’s chance is about 0.1% — this one is 3× that.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 4 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 4 across plans
  • Costs ≥ $950/fill · avg $1,766.58 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Prolia

Regulatory

Application
BLA761444
TE code
Approval date
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Denosumab (Injection, Solution)

LabelerStrengthFirst seenLast seen
Cordavis LimitedDENOSUMAB 60 mg/mLJul 15, 2026Sep 2, 2026
Organon LLCDENOSUMAB 120 mg/1.7mLJul 15, 2026Sep 2, 2026
Organon LLCDENOSUMAB 60 mg/mLJul 15, 2026Sep 2, 2026
Samsung BioLogics Co. LTDDENOSUMAB-DSSB 120 mg/1.7mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Bildyos — NDC 78206-0193-01," retrieved September 3, 2026, https://drugdashboards.com/drug/78206019301.

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