Lazcluze

lazertinib · LAZERTINIB 240 mg/1 · Tablet, Film Coated · Oral · Janssen Biotech, Inc.

NDC 57894-0240-99 · 1 DOSE PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 DOSE PACK · 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.

Medicare Part D

Matched to CMS's representative package for this drug (NDC 57894-0240-30) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ 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ⓘ

$621.91per unit

middle half $594.56–$640.56 · 5,496 plans · Apr 1, 2026

Est. net of rebatesⓘ

$373.14–$466.43

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 6 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

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

Where it's made

Janssen Cilag SpAItaly
analysis · label · manufacture · pack
Janssen Pharmaceutica NVBelgium
analysis · api manufacture · manufacture
Johnson & Johnson Private LimitedIndia
analysis
Yuhan Chemical Inc.Korea, South
api manufacture

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 1 of 6 public criteria. Why that matters →

Part D specialty tier
Costs ≥ $950/fill · avg $17,900.86 per prescription
Biologic (BLA)
Injectable / infused
Orphan-drug exclusivity
REMS program

Regulatory

Application: NDA219008
TE code: —
Approval date: Aug 19, 2024
Patents / exclusivity: 16 patents, 2 exclusivities

Type	Number / code	Expires
exclusivity	NCE	Aug 19, 2029
exclusivity	NCE	Aug 19, 2029
patent	11850248	Aug 1, 2041
patent	11850248	Aug 1, 2041
patent	12138351	Apr 13, 2041
patent	12138351	Apr 13, 2041
patent	11879013	May 21, 2040
patent	11879013	May 21, 2040
patent	12599606	May 14, 2040
patent	12599606	May 14, 2040
patent	11453656	Apr 18, 2038
patent	11981659	Apr 18, 2038

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of lazertinib (Tablet, Film Coated)

Labeler	Strength	First seen	Last seen
Janssen Biotech, Inc.	LAZERTINIB 240 mg/1	Jul 15, 2026	Sep 2, 2026
Janssen Biotech, Inc.	LAZERTINIB 80 mg/1	Jul 15, 2026	Sep 2, 2026

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

Cite this page

DrugDashboards, "Lazcluze — NDC 57894-0240-99," retrieved September 3, 2026, https://drugdashboards.com/drug/57894024099.

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