DrugDashboards

Nubeqa

darolutamide · DAROLUTAMIDE 300 mg/1 · Tablet, Film Coated · Oral · Bayer HealthCare Pharmaceuticals Inc.

NDC 50419-0395-01 · 1 BOTTLE in 1 CARTON / 120 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.

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)$110.35per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$120.17per unitnegotiated price across 5,496 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$75.35per unitBayer HealthCare Pharmaceuticals, Inc. · Jan 1, 2026
  • List price (WAC, as filed)$15,100.80per packageBayer · Jan 1, 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
$120.17per unit
middle half $118.29$125.45 · 5,496 plans · Apr 1, 2026
Est. net of rebates
$72.10–$90.13
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 98% · step therapy 0% · qty limit 80%

*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 10 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
$15,100.80
Reported to Texas DSHS · 2026 annual filing · Bayer Healthcare Pharmaceuticals, Inc

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

Medicaid spend (2025)

$108.2M
8,217 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

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

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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $12,783.10 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA212099
TE code
Approval date
Jul 30, 2019
Patents / exclusivity
10 patents, 1 exclusivities
TypeNumber / codeExpires
exclusivityI-971Jun 3, 2028
patent12329742Jun 17, 2042
patent12611397Jul 2, 2040
patent11168058Feb 27, 2038
patent10835515Jan 28, 2036
patent10010530Jan 28, 2036
patent10383853Jan 28, 2036
patent8975254Mar 25, 2033
patent11046713Oct 27, 2030
patent10711013Oct 27, 2030
patent9657003Oct 27, 2030

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of darolutamide (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Bayer HealthCare Pharmaceuticals Inc.DAROLUTAMIDE 300 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Nubeqa — NDC 50419-0395-01," retrieved September 3, 2026, https://drugdashboards.com/drug/50419039501.

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