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 2.4 mg/mL · Injection, Solution · Intrathecal · Biogen Inc.
NDC 64406-0058-01 · 1 VIAL, SINGLE-USE in 1 BOX / 5 mL in 1 VIAL, SINGLE-USE · NDA · View full market →
One drug, every price
The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.
ⓘ How this was built
Data sources
- CMS NADAC (pharmacy acquisition, weekly)
- CMS Part B ASP quarterly payment limits
- CMS Maximum Fair Prices (IRA negotiated, NDC-level)
- Medicare Part D Spending by Drug (data.cms.gov, name-matched)
- VA FSS / Big4 federal contract prices (va.gov, twice monthly)
- ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
- California SB-17 WAC filings (list price, per package)
Method
Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
- Part D plans paid (avg)$28,221.54per dosage unitgross, before rebates — matched by drug name · 2024
- Federal ceiling (Big4)$86,688.93per package of 5MLBiogen U.S. Corporation · Jan 1, 2026
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
$146,298.96
Reported to Texas DSHS · 2026 annual filing · Biogen, Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2025)
$48.5M
390 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 $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 64406-0058-01," retrieved September 3, 2026, https://drugdashboards.com/drug/64406005801.
Free to cite with attribution — see how the data is put together.