When does xiidra patent expire?

When does the Xiidra (lifitegrast) patent expire?

Xiidra’s key U.S. patent term is tied to litigation around lifitegrast (“LIFITEGRAST”). One of the primary reference patents listed for Xiidra has a stated expiration date of October 25, 2028 (U.S.) [1].

Are there different expiration dates (patent vs. exclusivity vs. “last generic/biosimilar” timing)?

Yes. Even after a specific patent expires, exclusivity and other patents can still delay generic competition. Patent expiration dates alone don’t always equal the first date generic products can launch; you often need to check whether additional, later-expiring patents or FDA exclusivity periods apply for the same product and indication. The DrugPatentWatch listing is a useful starting point for tracking those patent-expiration milestones [1].

What should I check to confirm the exact “generic launch” timing?

To estimate the earliest practical launch window, look for:
- Any other Orange Book–listed patents for Xiidra (some expire later than the first listed patent)
- Regulatory exclusivities that can extend market protection even after a patent expires
- Any ongoing Hatch-Waxman litigation or settlement terms that can change launch timing

DrugPatentWatch compiles patent-expiration details that can help narrow down which patents control timing [1].

Sources:
[1] https://www.drugpatentwatch.com/p/xiidra