Drug
Who makes baloxavir marboxil?
2 companies list baloxavir marboxil as a human prescription drug, including under the names Xofluza. Forms: granule, for solution; granule, for suspension; tablet, film coated. 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 baloxavir marboxil
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Genentech, Inc.United States | granule, for solution; granule, for suspension; tablet, film coated | NDANDA210854, NDA214410 | 5 | 8 |
| Sportpharm LLC | tablet, film coated | NDANDA210854 | 1 | 0 |
Bulk ingredient listings
- Evonik Operations GmbHGermany · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Shionogi Pharma Co., Ltd.Japan · 1 NDC
Orange Book patents
10 unexpired patents list baloxavir marboxil as the active ingredient, expiring between Jun 2030 and Apr 2041. Application holder: GENENTECH INC.
Enquiry
Common questions
- Who makes baloxavir marboxil?
- 2 companies list baloxavir marboxil as a human prescription drug in the openFDA NDC Directory, led by Genentech, Inc., Sportpharm LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Who supplies baloxavir marboxil active ingredient?
- 3 companies list baloxavir marboxil as a bulk ingredient, including Evonik Operations GmbH, MSN Laboratories Private Limited,, Shionogi Pharma Co., Ltd..