DrugDashboards

Lorbrena

lorlatinib · LORLATINIB 100 mg/1 · Tablet, Film Coated · Oral · Pfizer Laboratories Div Pfizer Inc

NDC 00069-0231-01 · 30 TABLET, FILM COATED 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)$485.61per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$726.24per unitnegotiated price across 5,496 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$525.74per unitPfizer 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
$726.24per unit
middle half $704.49$751.94 · 5,496 plans · Apr 1, 2026
Est. net of rebates
$435.74–$544.68
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
$21,359.47
Reported to Texas DSHS · 2026 annual filing · Pfizer Inc.

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

Medicaid spend (2025)

$11.3M
552 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 3 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $19,798.89 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA210868
TE code
Approval date
Nov 2, 2018
Patents / exclusivity
8 patents, 2 exclusivities
TypeNumber / codeExpires
exclusivityODE-349Mar 3, 2028
exclusivityODE-349Mar 3, 2028
patent11299500Oct 4, 2038
patent11299500Oct 4, 2038
patent11020376Jul 27, 2036
patent10420749Jul 27, 2036
patent11020376Jul 27, 2036
patent10420749Jul 27, 2036
patent8680111Mar 5, 2033
patent8680111Mar 5, 2033

Shortage history

  • Planned discontinuation Lorbrena, Tablet, 25 mg; 120 tablets bottle with a child-resistant closure (NDC 0069-0227-03)Jun 15, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of lorlatinib (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Pfizer Laboratories Div Pfizer IncLORLATINIB 100 mg/1Jul 15, 2026Sep 2, 2026
Pfizer Laboratories Div Pfizer IncLORLATINIB 25 mg/1Jul 15, 2026Sep 2, 2026
Pfizer Manufacturing Deutschland GmbH (Betriebssttte Freiburg)LORLATINIB 100 mg/1Jul 15, 2026Sep 2, 2026
Pfizer Manufacturing Deutschland GmbH (Betriebssttte Freiburg)LORLATINIB 25 mg/1Jul 15, 2026Sep 2, 2026
U.S. PharmaceuticalsLORLATINIB 25 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Lorbrena — NDC 00069-0231-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00069023101.

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