DrugDashboards

Elelyso

Taliglucerase alfa · TALIGLUCERASE ALFA 200 U/5mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Pfizer Laboratories Div Pfizer Inc

NDC 00069-0106-01 · 1 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS · BLA · 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%)$42.68per billing unit (10 UNITS)HCPCS J3060 · Jul 1, 2026
  • Part D plans paid (avg)$873.09per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal ceiling (Big4)$601.97per unitPfizer 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
$898.85
Reported to Texas DSHS · 2026 annual filing · Pfizer Inc.

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

Medicare Part B (ASP)

Payment limit per 10 UNITS
$42.675
HCPCS J3060 · 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 3 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $44,935.88 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
BLA022458
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 · TerminatedFeb 27, 2020
    Pfizer Inc.Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
  • Class II · TerminatedSep 19, 2018
    Pfizer Inc.Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.

Manufacturers of Taliglucerase alfa (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
Pfizer Laboratories Div Pfizer IncTALIGLUCERASE ALFA 200 U/5mLJul 15, 2026Sep 2, 2026
Pharmacia and Upjohn Company LLCTALIGLUCERASE ALFA 200 U/5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Elelyso — NDC 00069-0106-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00069010601.

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