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.
Lutathera
Lutetium Lu 177 dotatate · LUTETIUM OXODOTREOTIDE LU-177 10 mCi/mL · Injection · Intravenous · Advanced Accelerator Applications USA, Inc
NDC 69488-0003-01 · 1 VIAL in 1 PACKAGE / 20.5 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
$61,004.89
Reported to Texas DSHS · 2026 annual filing · Novartis Pharmaceuticals Corporation
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2025)
$969,431
33 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
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
- NDA208700
- TE code
- —
- Approval date
- Jan 26, 2018
- Patents / exclusivity
- 18 patents, 3 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | PED | Oct 23, 2031 |
| exclusivity | ODE-479 | Apr 23, 2031 |
| exclusivity | NPP | Apr 23, 2027 |
| patent | 12144873*PED | Jan 25, 2039 |
| patent | 12415003*PED | Jan 25, 2039 |
| patent | 12151003*PED | Jan 25, 2039 |
| patent | 12491272*PED | Jan 25, 2039 |
| patent | 10596278*PED | Jan 25, 2039 |
| patent | 10596276*PED | Jan 25, 2039 |
| patent | 12161732*PED | Jan 25, 2039 |
| patent | 11904027*PED | Jan 25, 2039 |
| patent | 12168063*PED | Jan 25, 2039 |
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 dotatate (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Advanced Accelerator Applications USA, Inc | LUTETIUM OXODOTREOTIDE LU-177 10 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, "Lutathera — NDC 69488-0003-01," retrieved September 3, 2026, https://drugdashboards.com/drug/69488000301.
Free to cite with attribution — see how the data is put together.