HETLIOZ — FDA application NDA205677
Listed sponsor: VANDA PHARMS INC · VNDA company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10149829 | 001 | listed patent expiry date: 2033-01-25 | U-2477 |
| Patent 10149829 | 001 | listed patent expiry date: 2033-01-25 | U-3006 |
| Patent 10449176 | 001 | listed patent expiry date: 2033-01-25 | U-2149 |
| Patent 10610510 | 001 | listed patent expiry date: 2033-01-25 | U-3009 |
| Patent 10610510 | 001 | listed patent expiry date: 2033-01-25 | U-2805 |
| Patent 10945988 | 001 | listed patent expiry date: 2033-01-25 | U-2149 |
| Patent 10980770 | 001 | listed patent expiry date: 2033-01-25 | U-3106 |
| Patent 10980770 | 001 | listed patent expiry date: 2033-01-25 | U-3107 |
| Patent 11285129 | 001 | listed patent expiry date: 2033-01-25 | U-3342 |
| Patent 11285129 | 001 | listed patent expiry date: 2033-01-25 | U-3343 |
| Patent 11633377 | 001 | listed patent expiry date: 2033-01-25 | U-2149 |
| Patent 11633377 | 001 | listed patent expiry date: 2033-01-25 | U-3003 |
| Patent 11826339 | 001 | listed patent expiry date: 2033-01-25 | U-3342 |
| Patent 11826339 | 001 | listed patent expiry date: 2033-01-25 | U-3343 |
| Patent 11833130 | 001 | listed patent expiry date: 2033-01-25 | U-2149 |
| Patent 11833130 | 001 | listed patent expiry date: 2033-01-25 | U-3003 |
| Patent 11850229 | 001 | listed patent expiry date: 2033-01-25 | U-3342 |
| Patent 11850229 | 001 | listed patent expiry date: 2033-01-25 | U-3343 |
| Patent 11918557 | 001 | listed patent expiry date: 2033-01-25 | U-3003 |
| Patent 11918557 | 001 | listed patent expiry date: 2033-01-25 | U-3865 |
| Patent 12201604 | 001 | listed patent expiry date: 2033-01-25 | U-3003 |
| Patent 12201604 | 001 | listed patent expiry date: 2033-01-25 | U-3865 |
| Patent 9060995 | 001 | listed patent expiry date: 2033-01-25 | U-1710 |
| Patent 9539234 | 001 | listed patent expiry date: 2033-01-25 | U-1934 |
| Patent 9539234 | 001 | listed patent expiry date: 2033-01-25 | U-3004 |
| Patent 9549913 | 001 | listed patent expiry date: 2033-01-25 | U-1486 |
| Patent 9855241 | 001 | listed patent expiry date: 2033-01-25 | U-2149 |
| Patent RE46604 | 001 | listed patent expiry date: 2033-01-25 | U-2147 |
| Patent 11918556 | 001 | listed patent expiry date: 2033-04-07 | U-3342 |
| Patent 11918556 | 001 | listed patent expiry date: 2033-04-07 | U-3343 |
| Patent 9730910 | 001 | listed patent expiry date: 2034-05-17 | U-2085 |
| Patent 9730910 | 001 | listed patent expiry date: 2034-05-17 | U-3005 |
| Patent 10610511 | 001 | listed patent expiry date: 2034-10-10 | U-3007 |
| Patent 10610511 | 001 | listed patent expiry date: 2034-10-10 | U-2615 |
| Patent 11141400 | 001 | listed patent expiry date: 2034-10-10 | U-2615 |
| Patent 11141400 | 001 | listed patent expiry date: 2034-10-10 | U-3007 |
| Patent 11786502 | 001 | listed patent expiry date: 2034-10-10 | U-3007 |
| Patent 11786502 | 001 | listed patent expiry date: 2034-10-10 | U-3739 |
| Patent 10071977 | 001 | listed patent expiry date: 2035-02-12 | drug substance, drug product |
| Patent 10829465 | 001 | listed patent expiry date: 2035-02-12 | drug substance, drug product |
| Patent 11566011 | 001 | listed patent expiry date: 2035-02-12 | drug substance, drug product |
| Patent 11760740 | 001 | listed patent expiry date: 2035-02-12 | drug substance, drug product |
| Patent 12049457 | 001 | listed patent expiry date: 2035-02-12 | drug substance, drug product |
| Patent 10376487 | 001 | listed patent expiry date: 2035-07-27 | U-2615 |
| Patent 10376487 | 001 | listed patent expiry date: 2035-07-27 | U-3007 |
| Patent 10179119 | 001 | listed patent expiry date: 2035-08-29 | U-3003 |
| Patent 11266622 | 001 | listed patent expiry date: 2035-08-29 | U-3003 |
| Patent 11759446 | 001 | listed patent expiry date: 2041-02-21 | U-3003 |
| Exclusivity ODE-330 | 001 | listed exclusivity date: 2027-12-01 | FDA code as listed |
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 · CHEMBL2103822
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.