Prescription medicine
Eplontersen Brand names: Wainua; first approved as Wainua (Autoinjector)
Eplontersen (Wainua) 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 eplontersen FDA label on DailyMed (effective April 15, 2026, AstraZeneca Pharmaceuticals LP); the NDA 217388 record on Drugs@FDA; every eplontersen label on DailyMed.
Highlights of the record
FDA label of April 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageWAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Forms and strengths
- 45 mg/.8ml
Injection (solution).
On the market
- Earliest approval on file
- December 21, 2023 Wainua (Autoinjector), Astrazeneca Ab; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- August 25, 2034 Wainua 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
- 168 through July 30, 2026
What is eplontersen used for?
From the label: indications and usageWAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. WAINUA is a transthyretin-directed antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
FDA pharmacologic class: Antisense Oligonucleotide and Transthyretin-directed RNA Interaction.
Source: FDA drug label (WAINUA), AstraZeneca Pharmaceuticals LP, effective April 15, 2026 (SPL set d7dcb847-71dd-4fff-82d0-d43a465fc096), via openFDA; the full label on DailyMed
Is there a generic for eplontersen (Wainua)?
No generic eplontersen is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Wainua injection: the compound patent runs to August 25, 2034. 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
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the eplontersen label say about other medicines?
The eplontersen 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 named | Section | What the label says |
|---|---|---|
| Vitamin a | warnings and precautions | WARNINGS AND PRECAUTIONS Reduced Serum Vitamin A Levels and Recommended Supplementation: Supplement with the recommended daily allowance of vitamin A. Refer to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur. |
Source: FDA drug label (WAINUA), AstraZeneca Pharmaceuticals LP, effective April 15, 2026 (SPL set d7dcb847-71dd-4fff-82d0-d43a465fc096), via openFDA; the full label on DailyMed
What do FAERS reports show for eplontersen?
The FDA Adverse Event Reporting System holds 168 reports that list eplontersen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 21 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.
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
- Eplontersen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other