For severe diarrhea-predominant irritable bowel syndrome (IBS). Sold as Lotronex. Every FDA application for this active ingredient: 1 branded and 6 generic.
As of Nov 15, 2026, FDA lists 7 applications for Alosetron Hydrochloride (sold as Lotronex), first approved Feb 9, 2000, with 3 new uses approved and 0 published complete response letters.
| Alosetron HCl | Part D | $7.6M | -15% | 2,860 |
| Lotronex | Part D | $1.1M | -17% | 33 |
| Feb 9, 2000 | LotronexNDA 21107 · New molecular entity | Legacy | 20 | Marketed |
| May 4, 2015 | Alosetron HydrochlorideANDA 200652 | Hikma | 7 | Discontinued |
| Dec 22, 2016 | Alosetron HydrochlorideANDA 206647 | Amneal Pharms | 5 | Marketed |
| Feb 23, 2018 | Alosetron HydrochlorideANDA 206113 | Ph Health | 4 | Discontinued |
| Jan 14, 2019 | Alosetron HydrochlorideANDA 209180 | Rising | 4 | Marketed |
| Sep 16, 2019 | Alosetron HydrochlorideANDA 211621 | Adaptis | 2 | Marketed |
| Sep 9, 2020 | Alosetron HydrochlorideANDA 213614 | Mankind Pharma | 4 | 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
Hikma