Drug facts
BrandXiidra (Lifitegrast)
No generic lifitegrast has an active Orange Book listing (a generic was first approved 08/04/2023); the latest Xiidra patent or exclusivity in the Orange Book runs to 12/18/2033. 1 staged generic application passed FDA review and waits on patents or exclusivity.
Xiidra was first approved by the FDA on 07/11/2016 under NDA 208073; the application holder is Bausch and Lomb Inc.
The latest NADAC for XIIDRA 5% EYE DROPS is $11.83 per unit (as of 10/28/2026).
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
2,605days until the latest patent expires
- Latest patent
- 12/18/2033Xiidra Orange Book
02Competition
- Generics
- No active generic listing in the Orange Book Orange Book
- Staged generics
- 1 passed FDA review, awaiting market entry FDA
- First generic approved
- 08/04/2023 Orange Book
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $11.83 per unitXIIDRA 5% EYE DROPS, as of 10/28/2026 CMS NADAC
- Latest recall
- 05/10/2022Class III, Lifitegrast, Novartis Pharmaceuticals Corporation FDA enforcement
04Product
- Application holder
- Bausch and Lomb Inc Orange Book
- Application
- NDA 208073 Orange Book
- First approved
- 07/11/2016 Orange Book
- Dosage forms
- solution/drops
- Routes
- ophthalmic
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.