EYSUVIS
NDA 210933 · New Drug Application (NDA) Prescription
LOTEPREDNOL ETABONATE
- Sponsor (Drugs@FDA)
- ALCON LABS INC Company: ALCON INC (ALC)
- First approved
- Latest action
Drugs on HealthTrade
No drug on HealthTrade cites this application. Novel approvals since 2015 by healthcare companies HealthTrade covers are listed from Drugs@FDA automatically, labelled “Not yet reviewed”; editors link the others.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | EYSUVIS LOTEPREDNOL ETABONATE | SUSPENSION/DROPS;OPHTHALMIC 0.25% | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Original 1 | Approved | standard | Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
17 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 10058511Product 001 | Drug product | U-2492 | ||
| 10646436Product 001 | Drug product | – | ||
| 10688045Product 001 | Drug product | – | ||
| 10857096Product 001 | Method of use | U-2985 | ||
| 10940108Product 001 | Method of use | U-2985 | ||
| 10945948Product 001 | Method of use | U-2985 | ||
| 10993908Product 001 | Method of use | U-3117 | ||
| 11219596Product 001 | Method of use | U-2985 | ||
| 11596599Product 001 | Method of use | U-2985 | ||
| 11642317Product 001 | Drug product | – | ||
| 11872318Product 001 | Drug product | – | ||
| 12115246Product 001 | Drug product | U-2985 | ||
| 9056057Product 001 | Drug product | U-2491 | ||
| 9393213Product 001 | Drug product | – | ||
| 9532955Product 001 | Method of use | U-2491 | ||
| 9737491Product 001 | Method of use | U-2492 | ||
| 9827191Product 001 | Drug product | U-2985 |
Orange Book exclusivities
No Orange Book exclusivities are listed for this application.
Prescription labels
The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.
Eysuvis
LOTEPREDNOL ETABONATE · ALCON LABORATORIES, INC. · OPHTHALMIC · Version 10 · effective
Indications and usage
1 INDICATIONS AND USAGE EYSUVIS is a corticosteroid indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. EYSUVIS is a corticosteroid indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. ( 1 )
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 71571-333 in openFDA (opens in a new tab) | Eysuvis loteprednol etabonate | ALCON LABORATORIES, INC. | SUSPENSION/ DROPS OPHTHALMIC | NDA | From |
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FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-11-03.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-11-03.
- openFDA drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label download 2026-11-03.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-11-03.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.