The short version
Just 3 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.
Spinraza
Nusinersen · NUSINERSEN 5.6 mg/mL · Injection, Solution · Intrathecal · Biogen Inc.
NDC 64406-0036-01 · 1 VIAL, SINGLE-USE in 1 BOX / 5 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.
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 $141,107.69 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA209531
- TE code
- —
- Approval date
- Dec 23, 2016
- Patents / exclusivity
- 15 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NS | Mar 27, 2029 |
| exclusivity | NS | Mar 27, 2029 |
| patent | 12013403 | Mar 4, 2036 |
| patent | 10436802 | Sep 11, 2035 |
| patent | 9926559 | Jan 9, 2034 |
| patent | 8361977 | Dec 23, 2030 |
| patent | 8361977 | Dec 23, 2030 |
| patent | 8361977 | Dec 23, 2030 |
| patent | 8980853 | Nov 24, 2030 |
| patent | 8980853 | Nov 24, 2030 |
| patent | 8980853 | Nov 24, 2030 |
| patent | 9717750 | Jun 17, 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 Nusinersen (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Biogen | NUSINERSEN 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Biogen | NUSINERSEN 5.6 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Biogen Inc. | NUSINERSEN 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Biogen Inc. | NUSINERSEN 2.4 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Biogen Inc. | NUSINERSEN 5.6 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Patheon Italia S.p.A. | NUSINERSEN 2.4 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, "Spinraza — NDC 64406-0036-01," retrieved September 3, 2026, https://drugdashboards.com/drug/64406003601.
Free to cite with attribution — see how the data is put together.