Prescription medicine
Tofersen Brand names: Qalsody
Tofersen (Qalsody) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tofersen FDA label on DailyMed (effective November 13, 2024, Biogen Inc.); the NDA 215887 record on Drugs@FDA; every tofersen label on DailyMed.
Highlights of the record
FDA label of November 13, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageQALSODY is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 ( SOD1 ) gene.
Forms and strengths
- 100 mg/15ml
Injection.
On the market
- Earliest approval on file
- April 25, 2023 Qalsody, Biogen Ma; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- April 1, 2035 Qalsody 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
- 503 through July 30, 2026
What is tofersen used for?
From the label: indications and usageQALSODY is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 ( SOD1 ) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). QALSODY is an antisense oligonucleotide indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 ( SOD1 ) gene. […]
FDA pharmacologic class: Antisense Oligonucleotide.
Source: FDA drug label (QALSODY), Biogen Inc., effective November 13, 2024 (SPL set 81356b45-1cb7-4eef-88ea-e44cc18b47c5), via openFDA; the full label on DailyMed
Is there a generic for tofersen (Qalsody)?
No generic tofersen is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Qalsody injection: the compound patent runs to April 1, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2035 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 tofersen?
The FDA Adverse Event Reporting System holds 503 reports that list tofersen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 105 are coded as a death and 128 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
- Tofersen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other