Prescription medicine
Acoltremon Brand names: Tryptyr
Acoltremon (Tryptyr) is a prescription medicine with an FDA approval on record since 2025. No generic is listed; pharmacies paid $14.09 per unit (Tryptyr 0.003% eye drop) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the acoltremon FDA label on DailyMed (effective December 18, 2025, Alcon Laboratories, Inc.); the NDA 217370 record on Drugs@FDA; every acoltremon label on DailyMed.
Highlights of the record
FDA label of December 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease.
Forms and strengths
- 0.03 mg/ml
Solution.
On the market
- Earliest approval on file
- May 28, 2025 Tryptyr, Alcon Labs Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 16, 2042 Tryptyr solution/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $14.09 per unit Tryptyr 0.003% eye drop
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4,326 through July 30, 2026
What is acoltremon used for?
From the label: indications and usageTRYPTYR 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.
FDA pharmacologic class: TRPM8 Thermoreceptor Agonist.
Source: FDA drug label (TRYPTYR), Alcon Laboratories, Inc., effective December 18, 2025 (SPL set 2b7715a1-035c-4002-b582-5238efee5d58), via openFDA; the full label on DailyMed
Is there a generic for acoltremon (Tryptyr)?
No generic acoltremon is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Tryptyr solution/drops, the last expiring on December 16, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acoltremon (Tryptyr)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $14.09 per unit (Tryptyr 0.003% eye drop). The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tryptyr 0.003% eye drop (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tryptyr 0.003% eye drop | Brand | $14.09 per unit | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for acoltremon?
The FDA Adverse Event Reporting System holds 4,326 reports that list acoltremon among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9 are coded as a death and 33 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,311, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Acoltremon side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other