DrugDashboards

Qfitlia

fitusiran · FITUSIRAN 50 mg/.5mL · Injection, Solution · Subcutaneous · Genzyme Corporation

NDC 58468-0348-01 · 1 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE · NDA · 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%)$131.20per billing unit (0.04 MG)HCPCS J7174 · Jul 1, 2026
  • Federal ceiling (Big4)$105,533.20per package of 0.5MLGenzyme Corporation · Dec 4, 2025

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

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
$162,852.60
Reported to Texas DSHS · 2026 annual filing · Genzyme Corporation

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

Medicare Part B (ASP)

Payment limit per 0.04 MG
$131.202
HCPCS J7174 · Jul 1, 2026 quarter · typically ASP + 6%

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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA219019
TE code
—
Approval date
Mar 28, 2025
Patents / exclusivity
6 patents, 6 exclusivities
TypeNumber / codeExpires
exclusivityODE-510Mar 28, 2032
exclusivityODE-511Mar 28, 2032
exclusivityODE-510Mar 28, 2032
exclusivityODE-511Mar 28, 2032
exclusivityNCEMar 28, 2030
exclusivityNCEMar 28, 2030
patent11091759Dec 7, 2036
patent11091759Dec 7, 2036
patent9127274Mar 22, 2033
patent9127274Mar 22, 2033
patent9376680Mar 15, 2033
patent9376680Mar 15, 2033

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of fitusiran (Injection, Solution)

LabelerStrengthFirst seenLast seen
Genzyme CorporationFITUSIRAN 20 mg/.2mLJul 15, 2026Sep 2, 2026
Genzyme CorporationFITUSIRAN 50 mg/.5mLJul 15, 2026Sep 2, 2026
Sanofi-Aventis Deutschland GmbHFITUSIRAN 50 mg/.5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Qfitlia — NDC 58468-0348-01," retrieved September 3, 2026, https://drugdashboards.com/drug/58468034801.

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