# SPINRAZA — FDA application NDA209531

Informational only - not investment advice.

Application NDA209531 · type NDA · FDA status: approved · original approval 2016-12-23

Listed sponsor: BIOGEN · [BIIB company profile](/company/BIIB/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | SPINRAZA | NUSINERSEN SODIUM | SOLUTION | INTRATHECAL | EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) | Prescription | not listed | Yes |
| 002 | SPINRAZA | NUSINERSEN SODIUM | SOLUTION | INTRATHECAL | EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML) | Prescription | not listed | Yes |
| 003 | SPINRAZA | NUSINERSEN SODIUM | SOLUTION | INTRATHECAL | EQ 50MG BASE/5ML (EQ 10MG BASE/ML) | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 7838657, product 001; listed patent expiry date: 2027-07-11.
- Patent 7838657, product 002; listed patent expiry date: 2027-07-11.
- Patent 7838657, product 003; listed patent expiry date: 2027-07-11.
- Patent 9717750, product 001; listed patent expiry date: 2030-06-17.
- Patent 9717750, product 001; listed patent expiry date: 2030-06-17.
- Patent 9717750, product 001; listed patent expiry date: 2030-06-17.
- Patent 9717750, product 001; listed patent expiry date: 2030-06-17.
- Patent 9717750, product 002; listed patent expiry date: 2030-06-17.
- Patent 9717750, product 002; listed patent expiry date: 2030-06-17.
- Patent 9717750, product 002; listed patent expiry date: 2030-06-17.
- Patent 9717750, product 002; listed patent expiry date: 2030-06-17.
- Patent 9717750, product 003; listed patent expiry date: 2030-06-17.
- Patent 9717750, product 003; listed patent expiry date: 2030-06-17.
- Patent 9717750, product 003; listed patent expiry date: 2030-06-17.
- Patent 9717750, product 003; listed patent expiry date: 2030-06-17.
- Patent 8980853, product 001; listed patent expiry date: 2030-11-24.
- Patent 8980853, product 002; listed patent expiry date: 2030-11-24.
- Patent 8980853, product 003; listed patent expiry date: 2030-11-24.
- Patent 8361977, product 001; listed patent expiry date: 2030-12-23.
- Patent 8361977, product 002; listed patent expiry date: 2030-12-23.
- Patent 8361977, product 003; listed patent expiry date: 2030-12-23.
- Patent 9926559, product 001; listed patent expiry date: 2034-01-09.
- Patent 10436802, product 001; listed patent expiry date: 2035-09-11.
- Patent 10436802, product 001; listed patent expiry date: 2035-09-11.
- Patent 10436802, product 001; listed patent expiry date: 2035-09-11.
- Patent 10436802, product 001; listed patent expiry date: 2035-09-11.
- Patent 10436802, product 001; listed patent expiry date: 2035-09-11.
- Patent 10436802, product 001; listed patent expiry date: 2035-09-11.
- Patent 12013403, product 001; listed patent expiry date: 2036-03-04.
- Patent 12013403, product 001; listed patent expiry date: 2036-03-04.
- Patent 12013403, product 001; listed patent expiry date: 2036-03-04.
- Patent 12013403, product 001; listed patent expiry date: 2036-03-04.
- Patent 12013403, product 001; listed patent expiry date: 2036-03-04.
- Patent 12013403, product 001; listed patent expiry date: 2036-03-04.
- Exclusivity NS, product 002; listed exclusivity date: 2029-03-27.
- Exclusivity NS, product 003; listed exclusivity date: 2029-03-27.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- NUSINERSEN · UNII 5Z9SP3X666 · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/BIIB/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA209531. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.