Prescription medicine
Lifitegrast Brand names: Xiidra
Lifitegrast (Xiidra) is a prescription medicine with an FDA approval on record since 2016. A generic is approved and listed by 1 labeler, but in the October 7, 2026 NADAC survey pharmacies bought only the brand, at $11.83 per unit (Xiidra 5% eye drops).
- Generic approved
Check it at the source: the lifitegrast FDA label on DailyMed (effective November 21, 2024, Bausch & Lomb Incorporated); the NDA 208073 record on Drugs@FDA; every lifitegrast label on DailyMed.
Highlights of the record
FDA label of November 21, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageXiidra ® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED).
Forms and strengths
- 50 mg/ml
Solution/ drops; for solution.
On the market
- Earliest approval on file
- July 11, 2016 Xiidra, Bausch And Lomb Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first August 4, 2023; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- December 18, 2033 Xiidra solution/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $11.83 per unit Xiidra 5% eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2022 0 Class I among all firms' recalls; latest May 10, 2022
- FAERS reports
- 16,243 through July 30, 2026
What is lifitegrast used for?
From the label: indications and usageXiidra ® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED).
FDA pharmacologic class: Lymphocyte Function-Associated Antigen-1 Antagonist.
Source: FDA drug label (Xiidra), Bausch & Lomb Incorporated, effective November 21, 2024 (SPL set 1a914080-a3c0-44be-b601-0ae3160e77eb), via openFDA; the full label on DailyMed
Is there a generic for lifitegrast (Xiidra)?
The FDA approved the first generic lifitegrast on August 4, 2023. 3 generic applications are approved; 0 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists lifitegrast from 1 labeler under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it. In the latest NADAC survey pharmacies bought only the brand, so a generic may not be on sale yet.
The Orange Book lists 11 patents for Xiidra solution/drops: the compound patent runs to October 21, 2030, and the last listed entry to December 18, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 earliest approval on file
- 2023 first generic approved
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lifitegrast (Xiidra)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $11.83 per unit (Xiidra 5% eye drops), up 3% from $11.49 on October 8, 2025. 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.
- Xiidra 5% eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Xiidra 5% eye drops | Brand | $11.83 per unit | n/a | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has lifitegrast been recalled?
The FDA's Enforcement Report lists 2 recalls naming lifitegrast since 2022: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 10, 2022 | Class III | Novartis Pharmaceuticals Corporation | Failed Impurities/Degradation Specifications. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for lifitegrast?
The FDA Adverse Event Reporting System holds 16,243 reports that list lifitegrast among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 293 are coded as a death and 660 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 received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Lifitegrast side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other