Xiidra generics — when can they launch?
Xiidra (LIFITEGRAST) · Bausch Health · 8 active US patents · 2 expired
Where Xiidra sits in the generic timeline
Imminent generic cliff: earliest active US patent for Xiidra expires in 2029 (~3 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Formulation — 4 patents
- Method of Use — 3 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by Xiidra patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-1900 | (no description) |
U-1880 | (no description) |
Sample patent estate
Showing 6 of 8 active US patents. View full estate on the Xiidra drug page →
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This patent discloses novel crystalline polymorphic forms of a compound that inhibits LFA-1 and methods of preparing and using it to treat LFA-1 mediated diseases.USPTO title: Crystalline pharmaceutical and methods of preparation and use thereof
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This patent protects novel crystalline polymorphic forms of a compound that inhibits LFA-1 and methods of preparing and using it to treat LFA-1 mediated diseases.USPTO title: Crystalline pharmaceutical and methods of preparation and use thereof
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This patent protects methods for treating LFA-1 mediated diseases, including dry eye disorders, using LFA-1 antagonists.USPTO title: Compositions and methods for treatment of eye disorders
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This patent protects novel crystalline polymorphic forms of a compound that inhibits LFA-1.USPTO title: Crystalline pharmaceutical and methods of preparation and use thereof
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This patent protects novel crystalline polymorphic forms of a compound that inhibits LFA-1, and methods for preparing and using those forms.USPTO title: Crystalline pharmaceutical and methods of preparation and use thereof
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This patent protects novel crystalline polymorphic forms of a compound that inhibits LFA-1, and methods for preparing and using those forms.USPTO title: Crystalline pharmaceutical and methods of preparation and use thereof
Sources
- FDA Orange Book — patents listed against Xiidra (NDA filed 2016)
- Xiidra drug profile — full patent estate, indications, clinical trials, pricing
- Bausch Health patent portfolio
- Patent cliff 2029 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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