mitomycin · Glaukos · NDA 022572
Mitosol
Earliest generic entry, as listed
21 May 2029
Blocked by patent: US 9649428. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9649428 | use U-2095 · sets the listed date | 21 May 2029 |
| US 7806265 | drug product | 1 Feb 2029 |
| US 9539241 | drug substance, drug product, use U-2095 | 2 Jan 2028 |
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 |
|---|---|---|---|
| 022572 · 001 · RLD | for solution, topical | 0.2MG/VIAL | 21 May 2029 |
Expired or delisted (2)
- US 8186511 · product · 19 Jul 2026
- US 9205075 · product · 19 Jul 2026