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.
Pylarify Truvu
Piflufolastat F-18 · PIFLUFOLASTAT F-18 120 mCi/mL · Injection · Intravenous · Aphelion LLC
NDC 85347-0001-01 · 50 mL in 1 VIAL, GLASS · NDA · View full market →
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.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
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
- NDA220089
- TE code
- —
- Approval date
- Mar 6, 2026
- Patents / exclusivity
- 6 patents, 1 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NCE | May 26, 2026 |
| patent | 10947197 | Jun 9, 2037 |
| patent | 11851407 | Jun 9, 2037 |
| patent | 8778305 | Sep 21, 2030 |
| patent | 9861713 | Jul 31, 2029 |
| patent | 12070513 | Jul 31, 2029 |
| patent | 8487129 | Nov 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)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aphelion LLC | PIFLUFOLASTAT F-18 120 mCi/mL | Jul 15, 2026 | Sep 2, 2026 |
| Progenics Pharmaceuticals, Inc. | PIFLUFOLASTAT F-18 80 mCi/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Pylarify Truvu — NDC 85347-0001-01," retrieved September 3, 2026, https://drugdashboards.com/drug/85347000101.
Free to cite with attribution — see how the data is put together.