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PlainMeds

Prescription medicine

Risdiplam Brand names: Evrysdi

Risdiplam (Evrysdi) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the risdiplam FDA label on DailyMed (effective February 19, 2026, Genentech, Inc.); the NDA 213535 record on Drugs@FDA; every risdiplam label on DailyMed.

Highlights of the record

FDA label of February 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

EVRYSDI is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

Forms and strengths

  • 5 mg
  • 0.75 mg/ml

Powder for solution; tablet.

On the market

Earliest approval on file
August 7, 2020 Evrysdi, Genentech Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 15, 2041 Evrysdi for solution; 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)
1 since 2021 0 Class I among all firms' recalls; latest April 20, 2021

What is risdiplam used for?

From the label: indications and usage

EVRYSDI is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. EVRYSDI is a survival of motor neuron 2 (SMN2) splicing modifier indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

FDA pharmacologic class: Survival of Motor Neuron 2 Splicing Modifier.

Source: FDA drug label (EVRYSDI), Genentech, Inc., effective February 19, 2026 (SPL set eceb9a99-7191-4be5-87c3-0102707cf98e), via openFDA; the full label on DailyMed

Is there a generic for risdiplam (Evrysdi)?

No generic risdiplam is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 7 patents for Evrysdi for solution: the compound patent runs to April 15, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 2020 earliest approval on file
  • 2041 last listed patent
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has risdiplam been recalled?

The FDA's Enforcement Report lists 1 recall naming risdiplam since 2021: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
April 20, 2021Class IIIGenentech IncDefective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the risdiplam label say about other medicines?

The risdiplam label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Metformindrug interactionsSubstrates of Multidrug and Toxin Extrusion (MATE) Protein Transporters Based on in vitro data, EVRYSDI may increase plasma concentrations of drugs eliminated via MATE1 or MATE2-K [see Clinical Pharmacology (12.3) ], such as metformin.

Check risdiplam against other medicines

Source: FDA drug label (EVRYSDI), Genentech, Inc., effective February 19, 2026 (SPL set eceb9a99-7191-4be5-87c3-0102707cf98e), via openFDA; the full label on DailyMed

What next?

Check an interaction
what two or more labels say about each other