Drug
Who makes tasimelteon?
4 companies list tasimelteon as a human prescription drug, including under the names Hetlioz, Hetlioz LQ. Forms: capsule; capsule, gelatin coated; suspension. 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 tasimelteon
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | capsule; suspension | NDANDA205677, NDA214517 | 2 | 0 |
| Apotex Inc.Canada | capsule | ANDAANDA211607 | 1 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule, gelatin coated | ANDAANDA211601 | 1 | 6 |
| Amneal Pharmaceuticals NY LLC | capsule | ANDAANDA211654 | 1 | 0 |
Bulk ingredient listings
- Zhejiang Ausun Pharmaceutical Co., Ltd.China · 2 NDC
- Apotex Inc.Canada · 1 NDC
- Formosa Laboratories, Inc.Taiwan · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
Orange Book patents
33 unexpired patents list tasimelteon as the active ingredient, expiring between Jan 2033 and Feb 2041. Application holder: VANDA PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes tasimelteon?
- 4 companies list tasimelteon as a human prescription drug in the openFDA NDC Directory, led by Vanda Pharmaceuticals Inc., Apotex Inc., Teva Pharmaceutical Industries Ltd., Amneal Pharmaceuticals NY LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Hetlioz?
- 3 companies list tasimelteon under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies tasimelteon active ingredient?
- 4 companies list tasimelteon as a bulk ingredient, including Zhejiang Ausun Pharmaceutical Co., Ltd., Apotex Inc., Formosa Laboratories, Inc., MSN Life Sciences Private Limited.