crofelemer · Napo Pharms Inc · NDA 202292
Mytesi
Earliest generic entry, as listed
31 Oct 2031
Blocked by patent: US 8962680, US 9585868. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8962680 | use U-1319 | 31 Oct 2031 |
| US 9585868 | use U-1319 | 31 Oct 2031 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202292 · 001 · RLD | tablet, delayed release, oral | 125MG | 31 Oct 2031 |