DrugDashboards

Cathflo Activase

Alteplase · ALTEPLASE 2.2 mg/2mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Genentech, Inc.

NDC 50242-0041-10 · 10 VIAL in 1 CARTON / 2 mL in 1 VIAL · BLA · 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.

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%)$98.59per billing unit (1 MG)HCPCS J2997 · Jul 1, 2026
  • Federal ceiling (Big4)$132.39per unitGenentech USA, Inc. · Jan 1, 2026

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
$1,944.17
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 1 MG
$98.587
HCPCS J2997 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$114,365
680 prescriptions paid by Medicaid nationally · all Medicaid spend →

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 alteplase (injectable) in the next 90 days

sterile injectable · sole-source market

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
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
BLA103172
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 · TerminatedMay 20, 2024
    Genentech, Inc.Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
  • Class II · TerminatedMar 15, 2021
    Cardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Manufacturers of Alteplase (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
Genentech, Inc.ALTEPLASE 2.2 mg/2mLJul 15, 2026Sep 2, 2026
Patheon Manufacturing Services LLCALTEPLASE 2.2 mg/2mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Cathflo Activase — NDC 50242-0041-10," retrieved September 3, 2026, https://drugdashboards.com/drug/50242004110.

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