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.
Pluvicto
lutetium Lu 177 vipivotide tetraxetan · LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN 27 mCi/mL · Injection, Solution · Intravenous · Novartis Pharmaceuticals Corporation
NDC 00078-1217-61 · 1 VIAL, GLASS in 1 PACKAGE / 7.5 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.
Estimated fill cost
WAC per package, as filed
$52,703.17
Filed with Texas DSHS · effective Jul 1, 2026 · +$7185.67 increase
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
- NDA215833
- TE code
- —
- Approval date
- Mar 23, 2022
- Patents / exclusivity
- 5 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | I-965 | Mar 28, 2028 |
| exclusivity | NCE | Mar 23, 2027 |
| patent | 12208102 | Sep 18, 2041 |
| patent | 10398791 | Mar 23, 2036 |
| patent | 11951190 | Nov 12, 2035 |
| patent | 10406240 | Aug 15, 2028 |
| patent | 11318121 | Aug 15, 2028 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of lutetium Lu 177 vipivotide tetraxetan (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Novartis Pharmaceuticals Corporation | LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN 27 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, "Pluvicto — NDC 00078-1217-61," retrieved September 3, 2026, https://drugdashboards.com/drug/00078121761.
Free to cite with attribution — see how the data is put together.