Generic entry timeline

Miebo generics — when can they launch?

Miebo (PERFLUOROHEXYLOCTANE) · Bausch Health · 6 active US patents · 0 expired

Earliest patent expiry
2033-09-12
7 years remaining
Full patent estate to
2037-06-21
complete protection through 2037
FDA approval
2023
Bausch Health

Where Miebo sits in the generic timeline

Long-dated protection: earliest active US patent for Miebo 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 — 5 patents
  • Formulation — 1 patent

FDA U-codes carved out by Miebo 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-codeDescription
U-1900(no description)

Sample patent estate

Showing 6 of 6 active US patents. View full estate on the Miebo drug page →

  • US10058615 Method of Use · expires 2033-09-12
    This patent protects novel compositions of semifluorinated alkanes used as medicines for topical administration to an eye or ophthalmic tissue.
    USPTO title: Semifluorinated alkane compositions
  • US10449164 Method of Use · expires 2033-09-12
    This patent protects novel compositions of semifluorinated alkanes for topical use in treating ocular disorders such as dry eye and meibomian gland dysfunction.
    USPTO title: Methods of treating ocular disorders using semifluorinated alkanes
  • US10369117 Method of Use · expires 2033-09-12
    This patent protects novel compositions of semifluorinated alkanes used as topical eye medicines for treating dry eye and meibomian gland dysfunction.
    USPTO title: Compositions comprising mixtures of semifluorinated alkanes
  • US10576154 Method of Use · expires 2035-10-01
    This patent protects novel compositions of semifluorinated alkanes used as medicines for topical administration to an eye or ophthalmic tissue.
    USPTO title: Semifluorinated alkane compositions
  • US11357738 Formulation · expires 2036-09-29
    This patent protects compositions of semifluorinated compounds for topical administration to the eye as medicaments.
    USPTO title: Semifluorinated compounds and their compositions
  • US10507132 Method of Use · expires 2037-06-21
    This patent protects a method for administering ophthalmic compositions in a dropwise manner, preferably using semifluorinated alkanes, for preventing or treating ocular diseases or disorders.
    USPTO title: Topical administration method

Sources

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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