DrugDashboards

Pylarify

Piflufolastat F-18 · PIFLUFOLASTAT F-18 80 mCi/mL · Injection · Intravenous · Progenics Pharmaceuticals, Inc.

NDC 71258-0022-01 · 50 mL in 1 VIAL, MULTI-DOSE · 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.

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.

Medicaid spend (2025)

$2.5M
743 prescriptions paid by Medicaid nationally · all Medicaid spend →

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 1 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
NDA214793
TE code
—
Approval date
May 26, 2021
Patents / exclusivity
6 patents, 1 exclusivities
TypeNumber / codeExpires
exclusivityNCEMay 26, 2026
patent10947197Jun 9, 2037
patent11851407Jun 9, 2037
patent8778305Sep 21, 2030
patent12070513Jul 31, 2029
patent9861713Jul 31, 2029
patent8487129Nov 7, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Piflufolastat F-18 (Injection)

LabelerStrengthFirst seenLast seen
Aphelion LLCPIFLUFOLASTAT F-18 120 mCi/mLJul 15, 2026Sep 2, 2026
Progenics Pharmaceuticals, Inc.PIFLUFOLASTAT F-18 80 mCi/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Pylarify — NDC 71258-0022-01," retrieved September 3, 2026, https://drugdashboards.com/drug/71258002201.

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