RHOPRESSA
NDA 208254 · New Drug Application (NDA) Prescription
NETARSUDIL MESYLATE
- Sponsor (Drugs@FDA)
- ALCON LABS INC Company: ALCON INC (ALC)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | RHOPRESSA NETARSUDIL MESYLATE | SOLUTION/DROPS;OPHTHALMIC EQ 0.02% BASE | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 14 | Approved | standard | Labeling | Letter for Supplement 14 (opens in a new tab)Label for Supplement 14 (opens in a new tab) | |
| Supplement 3 | Approved | standard | Labeling | Label for Supplement 3 (opens in a new tab) | |
| Original 1 | Approved | standard | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
15 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 10532993Product 001 | Method of use | U-1524 | ||
| 10882840Product 001 | Method of use | U-1524 | ||
| 11021456Product 001 | Method of use | U-1524 | ||
| 8450344Product 001 | Drug substance, Drug product | U-1524 | ||
| 9096569Product 001 | Drug substance, Drug product | U-1524 | ||
| 11618748Product 001 | Method of use | U-1524 | ||
| 11028081Product 001 | Method of use | U-1524 | ||
| 10174017Product 001 | Drug substance, Drug product | U-1524 | ||
| 10654844Product 001 | Drug substance, Drug product | U-1524 | ||
| 8394826Product 001 | Drug substance, Drug product | U-1524 | ||
| 9415043Product 001 | Drug substance | – | ||
| 9931336Product 001 | Drug substance, Drug product | U-1524 | ||
| 10588901Product 001 | Drug substance, Drug product | U-1524 | ||
| 11185538Product 001 | Drug product | – | ||
| 11020385Product 001 | Method of use | U-1524 |
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.
Rhopressa
NETARSUDIL · Alcon Laboratories, Inc. · OPHTHALMIC, TOPICAL · Version 17 · effective
Indications and usage
1 INDICATIONS AND USAGE RHOPRESSA is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. RHOPRESSA ® is a Rho kinase inhibitor indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 70727-497 in openFDA (opens in a new tab) | Rhopressa netarsudil | Alcon Laboratories, Inc. | SOLUTION/ DROPS OPHTHALMIC, TOPICAL | NDA | From |
FDA recalls load here.
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.