Generic entry timeline

Klisyri generics — when can they launch?

Klisyri (TIRBANIBULIN) · Almirall · 6 active US patents · 0 expired

Earliest patent expiry
2027-12-28
2 years remaining
Full patent estate to
2038-09-07
complete protection through 2038
FDA approval
2020
Almirall

Where Klisyri sits in the generic timeline

Imminent generic cliff: earliest active US patent for Klisyri expires in 2027 (~2 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.

  • Method of Use — 3 patents
  • Composition of Matter — 2 patents
  • Formulation — 1 patent

FDA U-codes carved out by Klisyri 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-3015(no description)

Sample patent estate

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

  • US10323001 Formulation · expires 2027-12-28
    This patent protects compositions of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide and its salts, along with methods for making and using them.
    USPTO title: Compositions for modulating a kinase cascade and methods of use thereof
  • US7851470 Method of Use · expires 2029-02-02
    This patent protects compounds and methods for modulating one or more components of a kinase cascade.
    USPTO title: Composition and methods for modulating a kinase cascade
  • US7300931 Composition of Matter · expires 2030-12-28
    This patent protects compounds and methods for treating cell proliferation disorders.
    USPTO title: Compositions for treating cell proliferation disorders
  • US11497750 Method of Use · expires 2038-03-12
    This patent protects methods of treating and/or preventing actinic keratosis by administering a therapeutically effective amount of KX-01 to a subject in need thereof.
    USPTO title: Methods of treating and/or preventing actinic keratosis
  • US10617693 Method of Use · expires 2038-03-12
    This patent protects methods of treating and/or preventing actinic keratosis by administering a therapeutically effective amount of KX-01 to a subject.
    USPTO title: Methods of treating and/or preventing actinic keratosis
  • US10669236 Composition of Matter · expires 2038-09-07
    This patent protects solid forms A, B, and C of the compound 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide.
    USPTO title: Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide

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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