DrugDashboards

Erzofri extended-release

paliperidone palmitate · PALIPERIDONE PALMITATE 351 mg/2.25mL · Injection · Intramuscular · Shandong Luye Pharmaceutical Co., Ltd.

NDC 72526-0110-21 · 1 SYRINGE, GLASS in 1 KIT / 2.25 mL in 1 SYRINGE, GLASS · NDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. Historically, drugs in this position went on to a new shortage within 90 days about 0.4% of the time — roughly 3× the typical drug (0.1%).

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 72526-0110-11) — 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ⓘ
$2,713.84per unit
middle half $2,710.37–$2,791.88 · 1,836 plans · Apr 1, 2026
Est. net of rebatesⓘ
$1,628.30–$2,035.38
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
33%of plans cover it
tier 5 · prior auth 5% · step therapy 1% · qty limit 87%

*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 4 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.

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for paliperidone palmitate (injectable) in the next 90 days

sterile injectable · sole-source market · price up 2% YoY

For scale: the typical drug’s chance is about 0.1% — this one is 3× that.

Backtested statistical model over the whole market, not this package alone. Model details →

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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $3,652.84 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA216352
TE code
—
Approval date
Jul 26, 2024
Patents / exclusivity
12 patents, 0 exclusivities
TypeNumber / codeExpires
patent11666573Sep 24, 2039
patent11666573Sep 24, 2039
patent11666573Sep 24, 2039
patent11666573Sep 24, 2039
patent11666573Sep 24, 2039
patent11666573Sep 24, 2039
patent12128049Oct 26, 2038
patent12128049Oct 26, 2038
patent12128049Oct 26, 2038
patent12128049Oct 26, 2038
patent12128049Oct 26, 2038
patent12128049Oct 26, 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 paliperidone palmitate (Injection)

LabelerStrengthFirst seenLast seen
Janssen Pharmaceuticals, Inc.PALIPERIDONE PALMITATE 234 mg/1.5mLJul 15, 2026Sep 2, 2026
Janssen Pharmaceuticals, Inc.PALIPERIDONE PALMITATE 39 mg/.25mLJul 15, 2026Sep 2, 2026
Janssen Pharmaceuticals, Inc.PALIPERIDONE PALMITATE 156 mg/mLJul 15, 2026Sep 2, 2026
Janssen Pharmaceuticals, Inc.PALIPERIDONE PALMITATE 78 mg/.5mLJul 15, 2026Sep 2, 2026
Janssen Pharmaceuticals, Inc.PALIPERIDONE PALMITATE 117 mg/.75mLJul 15, 2026Sep 2, 2026
Shandong Luye Pharmaceutical Co., Ltd.PALIPERIDONE PALMITATE 39 mg/.25mLJul 15, 2026Sep 2, 2026
Shandong Luye Pharmaceutical Co., Ltd.PALIPERIDONE PALMITATE 78 mg/.5mLJul 15, 2026Sep 2, 2026
Shandong Luye Pharmaceutical Co., Ltd.PALIPERIDONE PALMITATE 117 mg/.75mLJul 15, 2026Sep 2, 2026
Shandong Luye Pharmaceutical Co., Ltd.PALIPERIDONE PALMITATE 156 mg/mLJul 15, 2026Sep 2, 2026
Shandong Luye Pharmaceutical Co., Ltd.PALIPERIDONE PALMITATE 234 mg/1.5mLJul 15, 2026Sep 2, 2026
Shandong Luye Pharmaceutical Co., Ltd.PALIPERIDONE PALMITATE 351 mg/2.25mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Erzofri extended-release — NDC 72526-0110-21," retrieved September 3, 2026, https://drugdashboards.com/drug/72526011021.

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