tiopronin · Mission Pharmacal · NDA 211843
Thiola Ec
Earliest generic entry, as listed · earliest of 2 marketed strengths
14 Nov 2038
Blocked by patent: US 11458104. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11458104 | use U-3441 · sets the listed date | 14 Nov 2038 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211843 · 001 · RLD | tablet, delayed release, oral | 100MG | 14 Nov 2038 |
| 211843 · 002 · RLD | tablet, delayed release, oral | 300MG | 14 Nov 2038 |
Expired or delisted (1)
- ODE* · 28 Jun 2026