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.
Exondys 51
eteplirsen · ETEPLIRSEN 50 mg/mL · Injection · Intravenous · Sarepta Therapeutics, Inc.
NDC 60923-0284-10 · 1 VIAL, SINGLE-USE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-USE · 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
$8,000.00
Reported to Texas DSHS · 2026 annual filing · Sarepta Therapeutics, Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2025)
$190.8M
5,023 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 · avg $60,881.62 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA206488
- TE code
- —
- Approval date
- Sep 19, 2016
- Patents / exclusivity
- 10 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 9506058 | Mar 14, 2034 |
| patent | 9506058 | Mar 14, 2034 |
| patent | 10364431 | Mar 14, 2034 |
| patent | 10364431 | Mar 14, 2034 |
| patent | 10337003 | Mar 14, 2034 |
| patent | 10337003 | Mar 14, 2034 |
| patent | RE47769 | Feb 2, 2029 |
| patent | RE47769 | Feb 2, 2029 |
| patent | RE48468 | Oct 27, 2028 |
| patent | RE48468 | Oct 27, 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 eteplirsen (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Catalent Indiana, LLC | ETEPLIRSEN 100 mg/2mL | Jul 15, 2026 | Sep 2, 2026 |
| Catalent Indiana, LLC | ETEPLIRSEN 500 mg/10mL | Jul 15, 2026 | Sep 2, 2026 |
| Sarepta Therapeutics, Inc. | ETEPLIRSEN 50 mg/mL | Jul 15, 2026 | Aug 31, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Exondys 51 — NDC 60923-0284-10," retrieved September 3, 2026, https://drugdashboards.com/drug/60923028410.
Free to cite with attribution — see how the data is put together.