Tiopronin
As of the edition of 20 October 2026, Tiopronin is a small molecule: marketed, first approved in 1988 (US); US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1988
- Kind
- Small molecule
- Brand name
- Thiola
- First approved
- 11 August 1988 (US)
- Approvals on record
- 5 in 1 region
- Holder of the most recent approval
- Casper Pharma; 2 holders in all
- Registered trials
- 3, 0 stopped early
- Disease areas
- Inherited and neonatal; Pregnancy and women's health; Urinary and reproductive; Heart and blood vessels; Nervous system
US protection
US protection ended in 2026.
The last listed US exclusivity ended in 2026. The application that gives this date is held by Mission Pharmacal.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product3 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 3 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 3 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Mission Pharmacal | Acquired holder | 2003 to now |
| Casper Pharma | Later holder | 2026 to now |