Prescription medicine
Lotilaner Brand names: Xdemvy
Lotilaner (Xdemvy) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the lotilaner FDA label on DailyMed (effective August 10, 2024, Tarsus Pharmaceuticals, Inc.); the NDA 217603 record on Drugs@FDA; every lotilaner label on DailyMed.
Highlights of the record
FDA label of August 10, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageXDEMVY is indicated for the treatment of Demodex blepharitis.
Forms and strengths
- 2.5 mg/ml
Solution/ drops.
On the market
- Earliest approval on file
- July 24, 2023 Xdemvy, Tarsus; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 14, 2038 Xdemvy solution/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,098 through July 30, 2026
What is lotilaner used for?
From the label: indications and usageXDEMVY is indicated for the treatment of Demodex blepharitis. XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis.
FDA pharmacologic class: Ectoparasiticide.
Source: FDA drug label (XDEMVY), Tarsus Pharmaceuticals, Inc., effective August 10, 2024 (SPL set ccd9e37c-654e-4e84-8c85-6523457df979), via openFDA; the full label on DailyMed
Is there a generic for lotilaner (Xdemvy)?
No generic lotilaner is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Xdemvy solution/drops: the compound patent runs to January 17, 2030, and the last listed entry to December 14, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for lotilaner?
The FDA Adverse Event Reporting System holds 3,098 reports that list lotilaner among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 27 are coded as a death and 57 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 (1,253, against a median of 1 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?
- Lotilaner side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other