Drug
Who makes odevixibat?
2 companies list odevixibat as a human prescription drug, including under the names Bylvay. Forms: capsule; capsule, coated pellets. Routes: oral.
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 odevixibat
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| IPSEN MANUFACTURING IRELAND LIMITEDIreland | capsule; capsule, coated pellets | NDANDA215498 | 4 | 2 |
| Albireo Pharma, Inc. | capsule, coated pellets | NDANDA215498 | 4 | 0 |
Orange Book patents
16 unexpired patents list odevixibat as the active ingredient, expiring between Nov 2031 and Nov 2041. Application holder: IPSEN BIOPHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes odevixibat?
- 2 companies list odevixibat as a human prescription drug in the openFDA NDC Directory, led by IPSEN MANUFACTURING IRELAND LIMITED, Albireo Pharma, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.