Prescription medicine
Nusinersen Brand names: Spinraza
Nusinersen (Spinraza) is a prescription medicine with an FDA approval on record since 2016. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the nusinersen FDA label on DailyMed (effective March 31, 2026, Biogen Inc.); the NDA 209531 record on Drugs@FDA; every nusinersen label on DailyMed.
Highlights of the record
FDA label of March 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
Forms and strengths
- 2.4 mg/ml
- 5.6 mg/ml
- 10 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- December 23, 2016 Spinraza, Biogen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 4, 2036 Spinraza injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 7,655 through July 30, 2026
What is nusinersen used for?
From the label: indications and usageSPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients
FDA pharmacologic class: Antisense Oligonucleotide and Survival Motor Neuron-2-directed RNA Interaction.
Source: FDA drug label (Spinraza), Biogen Inc., effective March 31, 2026 (SPL set dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94), via openFDA; the full label on DailyMed
Is there a generic for nusinersen (Spinraza)?
No generic nusinersen is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Spinraza injection: the compound patent runs to December 23, 2030, and the last listed entry to March 4, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for nusinersen?
The FDA Adverse Event Reporting System holds 7,655 reports that list nusinersen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 790 are coded as a death and 2,369 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antisense oligonucleotides
- the pharmacologic class, with prices and generics
- Nusinersen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other