Xalatan generics — when can they launch?
Xalatan (LATANOPROST) · Thea Pharma · 20 active US patents · 0 expired
Where Xalatan sits in the generic timeline
All listed Orange Book patents for Xalatan have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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.
- Method of Use — 16 patents
- Formulation — 3 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by Xalatan 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-1524 | (no description) |
U-2400 | (no description) |
U-446 | (no description) |
Sample patent estate
Showing 6 of 20 active US patents. View full estate on the Xalatan drug page →
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This patent protects beta and gamma-amino isoquinoline amide compounds and substituted benzamide compounds useful as therapeutic agents for treating various diseases and conditions.USPTO title: Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
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This patent protects beta and gamma-amino isoquinoline amide compounds and substituted benzamide compounds useful as therapeutic agents for treating various diseases and conditions.USPTO title: Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
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This patent protects beta and gamma-amino isoquinoline amide compounds and substituted benzamide compounds useful as therapeutic agents for treating various diseases and conditions.USPTO title: Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
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This patent protects beta and gamma-amino isoquinoline amide compounds and substituted benzamide compounds useful as therapeutic agents for treating various diseases and conditions.USPTO title: Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
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This patent protects beta and gamma-amino isoquinoline amide compounds and substituted benzamide compounds useful as therapeutic agents for treating various diseases and conditions.USPTO title: Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
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This patent protects a pharmaceutical composition for ophthalmic use that includes one or more prostaglandin derivatives or salts and a stabilizing amount of polyethylene glycol hydroxystearate.USPTO title: Ophthalmic composition comprising a prostaglandin
Sources
- FDA Orange Book — patents listed against Xalatan (NDA filed 1996)
- Xalatan drug profile — full patent estate, indications, clinical trials, pricing
- Thea Pharma patent portfolio
- Patent cliff 2026 — 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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