Lotemax generics — when can they launch?
Lotemax (LOTEPREDNOL ETABONATE) · Bausch Health · 32 active US patents · 0 expired
Where Lotemax sits in the generic timeline
Long-dated protection: earliest active US patent for Lotemax extends to 2033 (~7 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 22 patents
- Formulation — 10 patents
FDA U-codes carved out by Lotemax 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-2491 | (no description) |
U-2985 | (no description) |
U-2492 | (no description) |
U-3117 | (no description) |
U-3278 | (no description) |
U-4025 | (no description) |
U-3011 | (no description) |
U-2493 | (no description) |
U-2764 | (no description) |
Sample patent estate
Showing 6 of 32 active US patents. View full estate on the Lotemax drug page →
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This patent protects methods and compositions for making particles that can efficiently transport pharmaceutical agents through mucus barriers in the body.USPTO title: Nanocrystals, compositions, and methods that aid particle transport in mucus
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This patent protects methods and compositions that aid in transporting particles through mucus barriers in the body.USPTO title: Nanocrystals, compositions, and methods that aid particle transport in mucus
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This patent protects methods and compositions that aid in transporting particles through mucus barriers in the body.USPTO title: Nanocrystals, compositions, and methods that aid particle transport in mucus
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This patent protects compositions and methods that aid particle transport in mucus for various applications, including ophthalmic uses.USPTO title: Compositions and methods for ophthalmic and/or other applications
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This patent protects methods and compositions that aid in transporting particles through mucus barriers in the body.USPTO title: Nanocrystals, compositions, and methods that aid particle transport in mucus
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This patent protects compositions and methods that aid particle transport in mucus for various applications, including ophthalmic use.USPTO title: Compositions and methods for ophthalmic and/or other applications
Sources
- FDA Orange Book — patents listed against Lotemax (NDA filed 1998)
- Lotemax drug profile — full patent estate, indications, clinical trials, pricing
- Bausch Health patent portfolio
- Patent cliff 2033 — 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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