Prevents cystine stone formation. Sold as Thiola, Thiola Ec, Tiocystin. Every FDA application for this active ingredient: 3 branded and 6 generic.
As of Nov 15, 2026, FDA lists 9 applications for Tiopronin (sold as Thiola, Thiola Ec, Tiocystin), first approved Aug 11, 1988, with 0 new uses approved and 0 published complete response letters.
| Thiola EC | Part D | $28.0M | +5% | 299 |
| Thiola | Part D | $3.9M | +9% | 53 |
| Tiopronin | Part D | $1.9M | +106% | 63 |
| Venxxiva | Part D | $179K | New | 0 |
| Aug 11, 1988 | ThiolaNDA 19569 · New molecular entity | Mission Pharma | 3 | Marketed |
| Jun 28, 2019 | Thiola EcNDA 211843 · New dosage form | Mission Pharmacal | 1 | Marketed |
| Apr 26, 2021 | TioproninANDA 214326 | Teva Pharms USA Inc | 0 | Marketed |
| Jun 2, 2022 | TioproninANDA 216198 | Ph Health | 0 | Discontinued |
| Feb 24, 2023 | TioproninANDA 217219 | Ph Health | 0 | Marketed |
| Aug 15, 2023 | TioproninANDA 216278 | Amneal | 1 | Discontinued |
| Jan 30, 2024 | VenxxivaANDA 216990 | Torrent | 1 | Marketed |
| Jul 22, 2024 | TioproninANDA 216456 | Teva Pharms Inc | 0 | Marketed |
| Jun 2, 2026 | TiocystinNDA 212927 · New formulation or manufacturer | Casper Pharma LLC | 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
