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.
Imlygic
talimogene laherparepvec · TALIMOGENE LAHERPAREPVEC 1000000 [PFU]/mL · Injection, Suspension · Intralesional · Amgen Inc
NDC 55513-0078-01 · 1 VIAL in 1 CARTON / 1 mL in 1 VIAL · BLA · 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.
Estimated fill cost
WAC per package, as filed
$73.36
Reported to Texas DSHS · 2026 annual filing · Amgen Usa Inc
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 1 million�PFU
$77.339
HCPCS J9325 · Jul 1, 2026 quarter · typically ASP + 6%
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- West Services and Solutions LLCUnited Statesanalysis
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
- BLA125518
- 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 talimogene laherparepvec (Injection, Suspension)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Amgen Inc | TALIMOGENE LAHERPAREPVEC 1000000 [PFU]/mL | Jul 15, 2026 | Sep 2, 2026 |
| Amgen Inc | TALIMOGENE LAHERPAREPVEC 100000000 [PFU]/mL | Jul 15, 2026 | Sep 2, 2026 |
| IDT Biologika GmbH | TALIMOGENE LAHERPAREPVEC 1000000 [PFU]/mL | Jul 15, 2026 | Sep 2, 2026 |
| IDT Biologika GmbH | TALIMOGENE LAHERPAREPVEC 100000000 [PFU]/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Imlygic — NDC 55513-0078-01," retrieved September 3, 2026, https://drugdashboards.com/drug/55513007801.
Free to cite with attribution — see how the data is put together.