Treats Non-24. Sold as Hetlioz, Hetlioz Lq. Every FDA application for this active ingredient: 2 branded and 3 generic.
As of Nov 15, 2026, FDA lists 5 applications for Tasimelteon (sold as Hetlioz, Hetlioz Lq), first approved Jan 31, 2014, with 1 new use approved and 0 published complete response letters.
| Hetlioz | Part D | $48.7M | -25% | 214 |
| Tasimelteon | Part D | $44.3M | +41% | 427 |
| Hetlioz Lq | Part D | $1.0M | -24% | 0 |
| Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric InsomniaInsomnia Disorder · Vanda Pharmaceuticals | Phase 3 | Recruiting | May 1, 2025 |
| Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 VariantSleep Wake Disorders, Sleep Disorders, Circadian Rhythm · Vanda Pharmaceuticals | Phase 3 | Recruiting | Nov 22, 2024 |
| Jan 31, 2014 | HetliozNDA 205677 · New molecular entity | Vanda Pharms Inc | 5 | Marketed |
| Dec 1, 2020 | Hetlioz LqNDA 214517 · New dosage form | Vanda Pharms Inc | 0 | Marketed |
| Dec 12, 2022 | TasimelteonANDA 211601 | Teva Pharms USA Inc | 0 | Marketed |
| Dec 20, 2022 | TasimelteonANDA 211607 | Apotex | 0 | Marketed |
| Jan 12, 2023 | TasimelteonANDA 211654 | Msn | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Apotex