Drug
Who makes eteplirsen?
2 companies list eteplirsen as a human prescription drug, including under the names Exondys 51. Forms: injection. Routes: intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing eteplirsen
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Catalent Indiana, LLCUnited States | injection | DRUG FOR FURTHER PROCESSING | 2 | 1 |
| Sarepta Therapeutics IncUnited States | injection | NDANDA206488 | 2 | 1 |
Bulk ingredient listings
- Polypeptide Laboratories Private LtdUnited States · 1 NDC
Orange Book patents
5 unexpired patents list eteplirsen as the active ingredient, expiring between Oct 2028 and Mar 2034. Application holder: SAREPTA THERAPEUTICS INC.
Enquiry
Common questions
- Who makes eteplirsen?
- 2 companies list eteplirsen as a human prescription drug in the openFDA NDC Directory, led by Catalent Indiana, LLC, Sarepta Therapeutics Inc. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Who supplies eteplirsen active ingredient?
- 1 company lists eteplirsen as a bulk ingredient, including Polypeptide Laboratories Private Ltd.