Lifitegrast

Treats dry eye disease (DED). Sold as Xiidra. Every FDA application for this active ingredient: 1 branded and 4 generic.

As of Nov 14, 2026, FDA lists 5 applications for Lifitegrast (sold as Xiidra), first approved Jul 11, 2016, with 0 new uses approved and 0 published complete response letters.

First approved: Jul 11, 2016
Applications: 5
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $555M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Xiidra	Part D	$555M	+10%	166,502

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

XIIDRA 5% EYE DROPS: $11.83 per unitBrand · +3% in a year

Clinical Trials

5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Clinical Evaluation of Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease Using In Vivo Confocal MicroscopyDry Eye · Toyos Clinic	Phase 4	Not yet recruiting	May 1, 2026
This is a Single Center, Open-label Prospective Study to Evaluate the Effect of Xiidra® (Lifitegrast Ophthalmic Solution 5.0%) on Tear Film Biomarkers in Dry EyeOcular Surface Disease, Dry Eye Syndrome (DES) · Pittsburgh Research Institute	Phase 4	Not yet recruiting	Mar 24, 2026
Switching From Xiidra to TRYPTYRDry Eye, Dry Eyes Chronic · Southern College of Optometry	Phase 4	Not yet recruiting	Dec 5, 2025
Phase III Clinical Study of Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye DiseaseDry Eye Disease (DED) · Lunan Better Pharmaceutical Co., LTD.	Phase 3	Recruiting	Mar 17, 2025
Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical MedicationsGlaucoma, Ocular Surface Disease · University of California, Los Angeles	—	Recruiting	Apr 21, 2020

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jul 11, 2016	XiidraNDA 208073 · New molecular entity	Bausch And Lomb Inc	3	Marketed
Aug 4, 2023	LifitegrastANDA 215081	Micro Labs	0	Discontinued
Nov 7, 2023	LifitegrastANDA 215063	Eugia Pharma	0	Discontinued
Oct 3, 2024	LifitegrastANDA 215058	Ingenus Pharms LLC	0	Discontinued
—	LifitegrastANDA 215126	Sun Pharm Inds Ltd	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA