DrugDashboards

HYLENEX Recombinant

Hyaluronidase · HYALURONIDASE (HUMAN RECOMBINANT) 150 [USP'U]/mL · Injection, Solution · Subcutaneous · Antares Pharma, Inc.

NDC 18657-0117-04 · 4 BOX in 1 CARTON / 1 VIAL in 1 BOX / 1 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. The price has held steady around $53.71 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)$53.71per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicare Part B pays (ASP+6%)$0.3640per billing unit (1 USP UNIT)HCPCS J3473 · Jul 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

$0$20.00$40.00$60.00Mar 2022Sep 2026$53.71
31 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$223.20
Reported to Texas DSHS · 2025 annual filing · Halozyme Therapeutics Inc.

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

Medicare Part B (ASP)

Payment limit per 1 USP UNIT
$0.364
HCPCS J3473 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$14,745
823 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30Elevated risk

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

  • 2 active manufacturers+20
  • 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 hyaluronidase (injectable) in the next 90 days

sterile injectable · sole-source market · price up 1% 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 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
BLA021859
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 · TerminatedSep 11, 2024
    Mckesson Medical-Surgical Inc. Corporate OfficecGMP Deviations: Temperature excursion

Manufacturers of Hyaluronidase (Injection, Solution)

LabelerStrengthFirst seenLast seen
Antares Pharma, Inc.HYALURONIDASE (HUMAN RECOMBINANT) 150 [USP'U]/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstHYALURONIDASE (HUMAN RECOMBINANT) 150 [USP'U]/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "HYLENEX Recombinant — NDC 18657-0117-04," retrieved September 3, 2026, https://drugdashboards.com/drug/18657011704.

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