DrugDashboards

Xolair PFS

omalizumab · OMALIZUMAB 75 mg/.5mL · Injection, Solution · Subcutaneous · Genentech, Inc.

NDC 50242-0214-03 · 1 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS · BLA · View full market →

The short version

Just 2 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.

  • Medicare Part B pays (ASP+6%)$46.59per billing unit (5 MG)HCPCS J2357 · Jul 1, 2026
  • Part D plans paid (avg)$1,381.49per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal ceiling (Big4)$470.53per package of 0.5MLGenentech USA, Inc. · Jan 1, 2026
  • List price (WAC, as filed)$776.88per packageGenentech USA · Jan 1, 2026

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 50242-0214-01) — 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
$1,517.89per unit
middle half $1,472.97$1,556.47 · 5,496 plans · Apr 1, 2026
Est. net of rebates
$910.73–$1,138.42
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 55%

*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
$776.88
Reported to Texas DSHS · 2026 annual filing · Genentech USA, Inc.

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

Medicare Part B (ASP)

Payment limit per 5 MG
$46.588
HCPCS J2357 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$8.9M
7,957 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 3 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $3,283.68 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
BLA103976
TE code
Approval date
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of omalizumab (Injection, Solution)

LabelerStrengthFirst seenLast seen
Genentech, Inc.OMALIZUMAB 150 mg/1.2mLJul 15, 2026Sep 2, 2026
Genentech, Inc.OMALIZUMAB 150 mg/mLJul 15, 2026Sep 2, 2026
Genentech, Inc.OMALIZUMAB 300 mg/2mLJul 15, 2026Sep 2, 2026
Genentech, Inc.OMALIZUMAB 75 mg/.5mLJul 15, 2026Sep 2, 2026
Novartis Pharma Stein AGOMALIZUMAB 75 mg/.5mLJul 15, 2026Sep 2, 2026
Novartis Pharma Stein AGOMALIZUMAB 150 mg/1.2mLJul 15, 2026Sep 2, 2026
Novartis Pharma Stein AGOMALIZUMAB 300 mg/2mLJul 15, 2026Sep 2, 2026
Novartis Pharma Stein AGOMALIZUMAB 150 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Xolair PFS — NDC 50242-0214-03," retrieved September 3, 2026, https://drugdashboards.com/drug/50242021403.

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