DrugDashboards

Adbry

tralokinumab-ldrm · TRALOKINUMAB 300 mg/2mL · Injection, Solution · Subcutaneous · LEO Pharma Inc.

NDC 50222-0350-91 · 1 SYRINGE, GLASS in 1 CARTON / 2 mL in 1 SYRINGE, GLASS · BLA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. A Class II recall hit this product in the past year (Leo Pharma Inc). One of its named manufacturing plants, Catalent Indiana, LLC, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 50222-0350-02) — 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
$1,046.72per unit
middle half $1,017.10$1,081.95 · 454 plans · Apr 1, 2026
Est. net of rebates
$628.03–$785.04
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
8%of plans cover it
tier 5 · prior auth 78% · step therapy 0% · qty limit 69%

*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

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 3 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $3,859.82 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
BLA761180
TE code
Approval date
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingFeb 10, 2026
    LEO PHARMA INCLack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.

Manufacturers of tralokinumab-ldrm (Injection, Solution)

LabelerStrengthFirst seenLast seen
LEO Pharma Inc.TRALOKINUMAB 150 mg/mLJul 15, 2026Sep 2, 2026
LEO Pharma Inc.TRALOKINUMAB 300 mg/2mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Adbry — NDC 50222-0350-91," retrieved September 3, 2026, https://drugdashboards.com/drug/50222035091.

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