lotilaner · Tarsus · NDA 217603
Xdemvy
Earliest generic entry, as listed
14 Dec 2038
Blocked by patent: US 10835517, US 11197847, US 11690826, US 11690827, US 11752137, US 12171750, US 12213964, US 12364685.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10835517 | use U-3674 · sets the listed date | 14 Dec 2038 |
| US 11197847 | use U-3674 · sets the listed date | 14 Dec 2038 |
| US 11690826 | use U-3674 · sets the listed date | 14 Dec 2038 |
| US 11690827 | use U-3674 · sets the listed date | 14 Dec 2038 |
| US 11752137 | drug product · sets the listed date | 14 Dec 2038 |
| US 12171750 | use U-3674 · sets the listed date | 14 Dec 2038 |
| US 12213964 | drug product · sets the listed date | 14 Dec 2038 |
| US 12364685 | drug product · sets the listed date | 14 Dec 2038 |
| US 8383659 | drug substance, drug product | 17 Jan 2030 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 24 Jul 2028 |
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 |
|---|---|---|---|
| 217603 · 001 · RLD | solution/drops, ophthalmic | 0.25% | 14 Dec 2038 |