TRYPTYR
NDA 217370 · New Drug Application (NDA) Prescription
ACOLTREMON
- 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 | TRYPTYR ACOLTREMON | SOLUTION/DROPS;OPHTHALMIC 0.003% | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| 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
5 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 10028920Product 001 | Method of use | U-1900 | ||
| 9095609Product 001 | Drug product | U-1900 | ||
| 9433679Product 001 | Method of use | U-1900 | ||
| 11850221Product 001 | Drug product | U-1900 | ||
| 12336971Product 001 | Method of use | U-1900 |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| NCE | 001 |
Codes as the Orange Book prints them; its preface explains each code.
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.
TRYPTYR
ACOLTREMON · Alcon Laboratories, Inc. · OPHTHALMIC, TOPICAL · Version 6 · effective
Indications and usage
1 INDICATIONS AND USAGE TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease. TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the 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 |
|---|---|---|---|---|---|
| 0065-8595 in openFDA (opens in a new tab) | TRYPTYR Acoltremon | Alcon Laboratories, Inc. | SOLUTION OPHTHALMIC, TOPICAL | 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.