Lifitegrast
As of the edition of 20 October 2026, Lifitegrast is a small molecule: marketed, first approved in 2016 (US); acts on ITGAL; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Xiidra
- First approved
- 11 July 2016 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Bausch Health
- Registered trials
- 25, 7 stopped early
- Disease areas
- Eye; Immune system; Hormones
US protection
US protection ends in 2030.
The last listed US drug-substance patent ends in 2030. The application that gives this date is held by Bausch Health.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product3 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Lifitegrast.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ITGAL | Integrin alpha-L | P20701 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 1 | 1 | 2 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 5 | 4 | 0 | 1 |
| Phase 4 | 11 | 5 | 2 | 3 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Originator and Lead sponsor of trials | 2009 to now |
| Bausch Health | Acquired holder and Lead sponsor of trials | 2024 to now |