DrugDashboards

Tofidence

Tocilizumab · TOCILIZUMAB 200 mg/10mL · Injection · Intravenous · Organon LLC

NDC 78206-0201-01 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE · 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.

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
$1,110.00
Reported to Texas DSHS · 2026 annual filing · Organon LLC

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

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 tocilizumab (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 →

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 $4,039.72 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
BLA761354
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 Tocilizumab (Injection)

LabelerStrengthFirst seenLast seen
Biogen MA IncTOCILIZUMAB 20 mg/mLJul 15, 2026Sep 3, 2026
Organon LLCTOCILIZUMAB 200 mg/10mLJul 15, 2026Sep 2, 2026
Organon LLCTOCILIZUMAB 400 mg/20mLJul 15, 2026Sep 2, 2026
Organon LLCTOCILIZUMAB 80 mg/4mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Tofidence — NDC 78206-0201-01," retrieved September 3, 2026, https://drugdashboards.com/drug/78206020101.

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