Generic entry timeline

Kybella generics — when can they launch?

Kybella (DEOXYCHOLIC ACID) · AbbVie · 14 active US patents · 0 expired

Earliest patent expiry
2027-12-10
2 years remaining
Full patent estate to
2032-02-17
complete protection through 2032
FDA approval
2015
AbbVie

Where Kybella sits in the generic timeline

Imminent generic cliff: earliest active US patent for Kybella 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 — 7 patents
  • Formulation — 6 patents
  • Composition of Matter — 1 patent

FDA U-codes carved out by Kybella 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-1690(no description)
U-1940(no description)

Sample patent estate

Showing 6 of 14 active US patents. View full estate on the Kybella drug page →

  • US7754230 Method of Use · expires 2027-12-10
    This patent discloses methods and compositions for reducing localized fat deposits using pharmacologically active detergents.
    USPTO title: Methods and related compositions for reduction of fat
  • US7622130 Method of Use · expires 2027-12-10
    This patent protects methods and compositions for non-surgically removing localized fat deposits using pharmacologically active detergents.
    USPTO title: Methods and compositions for the non-surgical removal of fat
  • US9949986 Method of Use · expires 2028-02-21
    This patent protects synthetic compositions of deoxycholic acid and related compounds, free of animal and pyrogenic moieties, and methods of their synthesis and use.
    USPTO title: Synthetic bile acid compositions and methods
  • US8883770 Formulation · expires 2028-02-21
    This patent protects synthetic compositions of deoxycholic acid and related compounds that are free of animal and pyrogenic moieties.
    USPTO title: Synthetic bile acid compositions and methods
  • US9636349 Method of Use · expires 2028-02-21
    This patent protects synthetic compositions of deoxycholic acid and related compounds, free of animal and pyrogenic moieties, and methods of their synthesis and use.
    USPTO title: Synthetic bile acid compositions and methods
  • US9522155 Method of Use · expires 2028-02-21
    This patent protects synthetic compositions of deoxycholic acid and related compounds that are free of animal and pyrogenic moieties.
    USPTO title: Synthetic bile acid compositions and methods

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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