# HETLIOZ — FDA application NDA205677

Informational only - not investment advice.

Application NDA205677 · type NDA · FDA status: approved · original approval 2014-01-31

Listed sponsor: VANDA PHARMS INC · [VNDA company profile](/company/VNDA/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | HETLIOZ | TASIMELTEON | CAPSULE | ORAL | 20MG | Prescription | AB | Yes |

## Orange Book patent and exclusivity listings

- Patent 10149829, product 001; listed patent expiry date: 2033-01-25.
- Patent 10149829, product 001; listed patent expiry date: 2033-01-25.
- Patent 10449176, product 001; listed patent expiry date: 2033-01-25.
- Patent 10610510, product 001; listed patent expiry date: 2033-01-25.
- Patent 10610510, product 001; listed patent expiry date: 2033-01-25.
- Patent 10945988, product 001; listed patent expiry date: 2033-01-25.
- Patent 10980770, product 001; listed patent expiry date: 2033-01-25.
- Patent 10980770, product 001; listed patent expiry date: 2033-01-25.
- Patent 11285129, product 001; listed patent expiry date: 2033-01-25.
- Patent 11285129, product 001; listed patent expiry date: 2033-01-25.
- Patent 11633377, product 001; listed patent expiry date: 2033-01-25.
- Patent 11633377, product 001; listed patent expiry date: 2033-01-25.
- Patent 11826339, product 001; listed patent expiry date: 2033-01-25.
- Patent 11826339, product 001; listed patent expiry date: 2033-01-25.
- Patent 11833130, product 001; listed patent expiry date: 2033-01-25.
- Patent 11833130, product 001; listed patent expiry date: 2033-01-25.
- Patent 11850229, product 001; listed patent expiry date: 2033-01-25.
- Patent 11850229, product 001; listed patent expiry date: 2033-01-25.
- Patent 11918557, product 001; listed patent expiry date: 2033-01-25.
- Patent 11918557, product 001; listed patent expiry date: 2033-01-25.
- Patent 12201604, product 001; listed patent expiry date: 2033-01-25.
- Patent 12201604, product 001; listed patent expiry date: 2033-01-25.
- Patent 9060995, product 001; listed patent expiry date: 2033-01-25.
- Patent 9539234, product 001; listed patent expiry date: 2033-01-25.
- Patent 9539234, product 001; listed patent expiry date: 2033-01-25.
- Patent 9549913, product 001; listed patent expiry date: 2033-01-25.
- Patent 9855241, product 001; listed patent expiry date: 2033-01-25.
- Patent RE46604, product 001; listed patent expiry date: 2033-01-25.
- Patent 11918556, product 001; listed patent expiry date: 2033-04-07.
- Patent 11918556, product 001; listed patent expiry date: 2033-04-07.
- Patent 9730910, product 001; listed patent expiry date: 2034-05-17.
- Patent 9730910, product 001; listed patent expiry date: 2034-05-17.
- Patent 10610511, product 001; listed patent expiry date: 2034-10-10.
- Patent 10610511, product 001; listed patent expiry date: 2034-10-10.
- Patent 11141400, product 001; listed patent expiry date: 2034-10-10.
- Patent 11141400, product 001; listed patent expiry date: 2034-10-10.
- Patent 11786502, product 001; listed patent expiry date: 2034-10-10.
- Patent 11786502, product 001; listed patent expiry date: 2034-10-10.
- Patent 10071977, product 001; listed patent expiry date: 2035-02-12.
- Patent 10829465, product 001; listed patent expiry date: 2035-02-12.
- Patent 11566011, product 001; listed patent expiry date: 2035-02-12.
- Patent 11760740, product 001; listed patent expiry date: 2035-02-12.
- Patent 12049457, product 001; listed patent expiry date: 2035-02-12.
- Patent 10376487, product 001; listed patent expiry date: 2035-07-27.
- Patent 10376487, product 001; listed patent expiry date: 2035-07-27.
- Patent 10179119, product 001; listed patent expiry date: 2035-08-29.
- Patent 11266622, product 001; listed patent expiry date: 2035-08-29.
- Patent 11759446, product 001; listed patent expiry date: 2041-02-21.
- Exclusivity ODE-330, product 001; listed exclusivity date: 2027-12-01.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- TASIMELTEON · UNII SHS4PU80D9 · [lmmol compound PTOIAAWZLUQTIO-GXFFZTMASA-N](https://lmmol.com/compound/PTOIAAWZLUQTIO-GXFFZTMASA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/VNDA/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA205677. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.