loteprednol etabonate · Alcon Labs Inc · NDA 210565
Inveltys
Blocked by patent: US 10058511, US 10646437, US 10688045, US 10864219, US 11219597, US 11642317, US 11872318, US 12115246, US 9056057, US 9393213, US 9532955, US 9737491, US 9827191.
Listed patents · 13 unexpired
14 Orange Book listing rows for 13 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10058511 | drug product, use U-2492 · sets the listed date | 3 May 2033 |
| US 10646437 | drug product · sets the listed date | 3 May 2033 |
| US 10688045 | drug product · sets the listed date | 3 May 2033 |
| US 10864219 | use U-3011 · sets the listed date | 3 May 2033 |
| US 11219597 | use U-3278, U-3279 | 3 May 2033 |
| US 11219597 listing row | use U-3278 · sets the listed date | 3 May 2033 |
| US 11219597 listing row | use U-3279 · sets the listed date | 3 May 2033 |
| US 11642317 | drug product · sets the listed date | 3 May 2033 |
| US 11872318 | drug product · sets the listed date | 3 May 2033 |
| US 12115246 | drug product, use U-4025 · sets the listed date | 3 May 2033 |
| US 9056057 | drug product, use U-2491 · sets the listed date | 3 May 2033 |
| US 9393213 | drug product · sets the listed date | 3 May 2033 |
| US 9532955 | use U-2491 · sets the listed date | 3 May 2033 |
| US 9737491 | use U-2492 · sets the listed date | 3 May 2033 |
| US 9827191 | drug product, use U-2493 · sets the listed date | 3 May 2033 |
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 |
|---|---|---|---|
| 210565 · 001 · RLD | suspension/drops, ophthalmic | 1% | 3 May 2033 |