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.
Imcivree
setmelanotide · SETMELANOTIDE 10 mg/mL · Solution · Subcutaneous · Rhythm Pharmaceuticals, Inc
NDC 72829-0010-01 · 1 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE · 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
$3,786.29
Reported to Texas DSHS · 2026 annual filing · Rhythm Pharmaceuticals, Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2025)
$70.5M
2,361 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
- NDA213793
- TE code
- —
- Approval date
- Nov 25, 2020
- Patents / exclusivity
- 3 patents, 6 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | ODE-509 | Dec 20, 2031 |
| exclusivity | ODE-508 | Dec 20, 2031 |
| exclusivity | ODE-402 | Jun 16, 2029 |
| exclusivity | I-987 | Mar 19, 2029 |
| exclusivity | NPP | Dec 20, 2027 |
| exclusivity | ODE-336 | Nov 25, 2027 |
| patent | 11129869 | Jul 4, 2034 |
| patent | 8039435 | Aug 21, 2032 |
| patent | 9458195 | Oct 13, 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 setmelanotide (Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Rhythm Pharmaceuticals, Inc | SETMELANOTIDE 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, "Imcivree — NDC 72829-0010-01," retrieved September 3, 2026, https://drugdashboards.com/drug/72829001001.
Free to cite with attribution — see how the data is put together.