pretomanid · Mylan Ireland Ltd · NDA 212862
Pretomanid
Earliest generic entry, as listed
14 Aug 2031
Blocked by exclusivity: GAIN.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| GAIN | qualified infectious disease product | 14 Aug 2031 |
| GAIN | qualified infectious disease product | 14 Aug 2029 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212862 · 001 · RLD | tablet, oral | 200MG | 14 Aug 2031 |
Expired or delisted (2)
- ODE-253 · 14 Aug 2026
- NCE · 14 Aug 2024