Sold as Ingrezza, Ingrezza Sprinkle. Every FDA application for this active ingredient: 2 branded and 3 generic.
As of Nov 15, 2026, FDA lists 5 applications for Valbenazine Tosylate (sold as Ingrezza, Ingrezza Sprinkle), first approved Apr 11, 2017, with 2 new uses approved and 0 published complete response letters.
| Ingrezza | Part D | $2.25B | +15% | 36,122 |
| Ingrezza Sprinkle | Part D | $31.4M | +775% | 970 |
| Ingrezza Initiation Pk(Tardiv) | Part D | $6.0M | +2% | 645 |
| Apr 11, 2017 | IngrezzaNDA 209241 · New molecular entity | Neurocrine | 10 | Marketed |
| Apr 5, 2024 | Valbenazine TosylateANDA 216064 | Lupin | 0 | Marketed |
| Apr 30, 2024 | Ingrezza SprinkleNDA 218390 · New dosage form | Neurocrine | 1 | Marketed |
| Aug 7, 2024 | Valbenazine TosylateANDA 216137 | Zydus Lifesciences | 1 | Discontinued |
| — | Valbenazine TosylateANDA 215984 | Teva Pharms Inc | 0 | Discontinued |
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
Lupin
Zydus Lifesciences