Lumigan generics — when can they launch?
Lumigan (BIMATOPROST) · · 9 active US patents · 0 expired
Where Lumigan sits in the generic timeline
Imminent generic cliff: earliest active US patent for Lumigan expires in 2026 (~1 year 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 — 2 patents
FDA U-codes carved out by Lumigan 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-2759 | (no description) |
U-1295 | (no description) |
Sample patent estate
Showing 6 of 9 active US patents. View full estate on the Lumigan drug page →
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This patent protects processes for making biocompatible implants containing a cyclic lipid therapeutic agent for intraocular use.USPTO title: Processes for making cyclic lipid implants for intraocular use
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This patent protects processes for making biocompatible implants containing a cyclic lipid therapeutic agent for intraocular use.USPTO title: Processes for making cyclic lipid implants for intraocular use
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This patent protects biocompatible intraocular implants that release a prostamide component to treat or reduce symptoms of an ocular condition.USPTO title: Hypotensive lipid-containing biodegradable intraocular implants and related methods
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This patent protects a composition of bimatoprost, an ophthalmic solution for treating glaucoma or ocular hypertension.USPTO title: Enhanced bimatoprost ophthalmic solution
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This patent protects biocompatible intraocular implants that release a prostamide component, such as bimatoprost, for an extended period to treat or reduce symptoms of ocular conditions.USPTO title: Hypotensive lipid-containing biodegradable intraocular implants and related methods
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This patent protects a new crystalline form of the drug bimatoprost, known as crystalline form II, which is the most stable form known to date.USPTO title: 7-[3,5-dihydroxy-2- (3-hydroxy-5-phenyl-pent-1-enyl)-cyclopentyl]-N-ethyl-hept-5-enamide (bimatoprost) in crystalline form II, methods for preparation, and methods for use thereof
Sources
- FDA Orange Book — patents listed against Lumigan (NDA filed 2001)
- Lumigan drug profile — full patent estate, indications, clinical trials, pricing
- 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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