The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Lumisight
Pegulicianine · PEGULICIANINE 10 mg/mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Lumicell, Inc.
NDC 82292-0040-10 · 10 VIAL in 1 CARTON / 3.9 mL in 1 VIAL · 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.
Estimated fill cost
WAC per package, as filed
$13,800.00
Reported to Texas DSHS · 2026 annual filing · Lumicell, Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
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
- NDA214511
- TE code
- —
- Approval date
- Apr 17, 2024
- Patents / exclusivity
- 6 patents, 1 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NCE | Apr 17, 2029 |
| patent | 9763577 | Sep 14, 2034 |
| patent | 9532835 | Dec 8, 2031 |
| patent | 10285759 | Dec 8, 2031 |
| patent | 9032965 | Dec 8, 2031 |
| patent | 9155471 | Oct 12, 2031 |
| patent | 11592396 | Sep 1, 2030 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Pegulicianine (Injection, Powder, Lyophilized, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Lumicell, Inc. | PEGULICIANINE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Lumisight — NDC 82292-0040-10," retrieved September 3, 2026, https://drugdashboards.com/drug/82292004010.
Free to cite with attribution — see how the data is put together.