Generic entry timeline

Inpefa generics — when can they launch?

Inpefa (SOTAGLIFLOZIN) · Lexicon Pharms Inc · 6 active US patents · 0 expired

Earliest patent expiry
2028-05-04
2 years remaining
Full patent estate to
2030-10-07
complete protection through 2030
FDA approval
2023
Lexicon Pharms Inc

Where Inpefa sits in the generic timeline

Imminent generic cliff: earliest active US patent for Inpefa expires in 2028 (~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 — 4 patents
  • Composition of Matter — 2 patents

FDA U-codes carved out by Inpefa 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-3628(no description)

Sample patent estate

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

  • US7781577 Method of Use · expires 2028-05-04
    USPTO title: Inhibitors of sodium glucose co-transporter 2 and methods of their use
  • US7781577 Method of Use · expires 2028-05-04
    This patent protects compounds and pharmaceutical compositions that inhibit sodium glucose co-transporter 2 for the treatment of diseases and disorders such as diabetes and obesity.
    USPTO title: Inhibitors of sodium glucose co-transporter 2 and methods of their use
  • US8476413 Method of Use · expires 2028-05-29
    This patent protects sulfanyl-tetrahydropyran-based compounds and their methods of use for treating diseases and disorders such as diabetes and obesity.
    USPTO title: Sulfanyl-tetrahydropyran-based compounds and methods of their use
  • US8476413 Method of Use · expires 2028-05-29
    This patent protects sulfanyl-tetrahydropyran-based compounds and their methods of use for treating diseases and disorders such as diabetes and obesity.
    USPTO title: Sulfanyl-tetrahydropyran-based compounds and methods of their use
  • US8217156 Composition of Matter · expires 2030-10-07
    This patent protects solid forms of the anhydrous molecule (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol.
    USPTO title: Solid forms of (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol and methods of their use
  • US8217156 Composition of Matter · expires 2030-10-07
    This patent protects solid forms of the anhydrous molecule (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol.
    USPTO title: Solid forms of (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol and methods of their use

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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