DrugDashboards

Vitrakvi

Larotrectinib · LAROTRECTINIB 100 mg/1 · Capsule · Oral · Bayer HealthCare Pharmaceuticals Inc.

NDC 50419-0391-01 · 60 CAPSULE in 1 BOTTLE · 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.

  • Part D plans paid (avg)$550.95per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$705.80per unitnegotiated price across 5,496 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$496.01per unitBayer HealthCare Pharmaceuticals, Inc. · 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
$705.80per unit
middle half $674.79$720.70 · 5,496 plans · Apr 1, 2026
Est. net of rebates
$423.48–$529.35
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 92%

*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
$42,547.20
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)

$1.1M
31 prescriptions paid by Medicaid nationally · all Medicaid spend →

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 · avg $37,105.59 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA210861
TE code
Approval date
Nov 26, 2018
Patents / exclusivity
30 patents, 0 exclusivities
TypeNumber / codeExpires
patent11337967May 16, 2037
patent11974998May 16, 2037
patent11974998May 16, 2037
patent11337967May 16, 2037
patent10799505Aug 15, 2036
patent10799505Aug 15, 2036
patent9782414Nov 16, 2035
patent10285993Nov 16, 2035
patent10285993Nov 16, 2035
patent10172861Nov 16, 2035
patent10813936Nov 16, 2035
patent9782414Nov 16, 2035

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class I · TerminatedNov 6, 2023
    Bayer Healthcare Pharmaceuticals Inc.Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

Manufacturers of Larotrectinib (Capsule)

LabelerStrengthFirst seenLast seen
Bayer HealthCare Pharmaceuticals Inc.LAROTRECTINIB 100 mg/1Jul 15, 2026Sep 2, 2026
Bayer HealthCare Pharmaceuticals Inc.LAROTRECTINIB 25 mg/1Jul 15, 2026Sep 2, 2026
Loxo Oncology, Inc.LAROTRECTINIB 100 mg/1Jul 15, 2026Sep 2, 2026
Loxo Oncology, Inc.LAROTRECTINIB 25 mg/1Jul 15, 2026Sep 2, 2026
Penn Pharmaceutical Services LimitedLAROTRECTINIB 100 mg/1Jul 15, 2026Sep 2, 2026
Penn Pharmaceutical Services LimitedLAROTRECTINIB 25 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Vitrakvi — NDC 50419-0391-01," retrieved September 3, 2026, https://drugdashboards.com/drug/50419039101.

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