DrugDashboards

Invega Trinza

paliperidone palmitate · PALIPERIDONE PALMITATE 546 mg/1.75mL · Injection, Suspension, Extended Release · Intramuscular · Janssen Pharmaceuticals, Inc

NDC 50458-0608-01 · 1 SYRINGE in 1 KIT / 1 mL in 1 SYRINGE · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price has held steady around $3993.21 per mL over the past year. Put together: worth watching — several of the pressures that precede supply trouble are present at once. 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.

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.

  • Pharmacies pay (NADAC)$3,993.21per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicare Part B pays (ASP+6%)$13.26per billing unit (1MG)HCPCS J2427 · Jul 1, 2026
  • Part D plans paid (avg)$3,985.21per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$4,060.57per unitnegotiated price across 5,396 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$5,272.81per unitJohnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc · Jan 1, 2026132% of what pharmacies pay — higher than 62% of drugs with this benchmark

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ⓘ
$4,060.57per unit
middle half $3,965.18–$4,179.38 · 5,396 plans · Apr 1, 2026
Est. net of rebatesⓘ
$2,436.34–$3,045.43
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
98%of plans cover it
tier 5 · prior auth 2% · step therapy 1% · qty limit 77%

*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

$0$2000.00$4000.00$6000.00May 2016Sep 2026$3993.21
47 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$4,079.13
Reported to Texas DSHS · 2026 annual filing · Johnson & Johnson Health Care Systems Inc

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

Medicare Part B (ASP)

Payment limit per 1MG
$13.262
HCPCS J2427 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$106.6M
16,147 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

40● Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30
  • sterile injectable+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

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 3 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $8,602.61 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA207946
TE code
—
Approval date
May 18, 2015
Patents / exclusivity
12 patents, 0 exclusivities
TypeNumber / codeExpires
patent11666697Nov 24, 2041
patent11666697Nov 24, 2041
patent11324751May 7, 2041
patent11304951May 7, 2041
patent11304951May 7, 2041
patent11324751May 7, 2041
patent12208100May 7, 2041
patent12208100May 7, 2041
patent10143693Apr 5, 2036
patent10143693Apr 5, 2036
patent10143693Apr 5, 2036
patent10143693Apr 5, 2036

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, Suspension, Extended Release)

LabelerStrengthFirst seenLast seen
Janssen Pharmaceuticals, IncPALIPERIDONE PALMITATE 1092 mg/3.5mLJul 15, 2026Sep 2, 2026
Janssen Pharmaceuticals, IncPALIPERIDONE PALMITATE 1560 mg/5mLJul 15, 2026Sep 2, 2026
Janssen Pharmaceuticals, IncPALIPERIDONE PALMITATE 273 mg/.88mLJul 15, 2026Sep 2, 2026
Janssen Pharmaceuticals, IncPALIPERIDONE PALMITATE 410 mg/1.32mLJul 15, 2026Sep 2, 2026
Janssen Pharmaceuticals, IncPALIPERIDONE PALMITATE 546 mg/1.75mLJul 15, 2026Sep 2, 2026
Janssen Pharmaceuticals, IncPALIPERIDONE PALMITATE 819 mg/2.63mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Invega Trinza — NDC 50458-0608-01," retrieved September 3, 2026, https://drugdashboards.com/drug/50458060801.

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