Generic entry timeline

Cubicin generics — when can they launch?

Cubicin (Daptomycin) · Baxter · 11 active US patents · 0 expired

Earliest patent expiry
2028-09-04
2 years remaining
Full patent estate to
2041-03-11
complete protection through 2041
FDA approval
2003
Baxter

Where Cubicin sits in the generic timeline

Imminent generic cliff: earliest active US patent for Cubicin 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 — 8 patents
  • Formulation — 3 patents

FDA U-codes carved out by Cubicin 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-1180(no description)
U-3175(no description)
U-3176(no description)
U-3981(no description)
U-3294(no description)

Sample patent estate

Showing 6 of 11 active US patents. View full estate on the Cubicin drug page →

  • US8003673 Method of Use · expires 2028-09-04
    This patent protects methods and formulations for using daptomycin to treat biofilms, particularly for salvaging infected central venous catheters.
    USPTO title: Daptomycin for the treatment of biofilm and catheter salvage
  • US9138456 Formulation · expires 2030-11-23
    This patent protects novel powder formulations of daptomycin, such as those containing daptomycin and sucrose, with improved stability and reconstitution times.
    USPTO title: Lipopeptide compositions and related methods
  • US9655946 Method of Use · expires 2033-09-11
    This patent protects lyophilized daptomycin formulations with improved reconstitution times, which can include various additives.
    USPTO title: Daptomycin formulations and uses thereof
  • US10357535 Method of Use · expires 2033-09-11
    This patent protects improved lyophilized daptomycin formulations with additives for faster reconstitution and methods for preparing and using them to treat bacterial infections and biofilms.
    USPTO title: Daptomycin formulations and uses thereof
  • US9655946 Method of Use · expires 2033-09-11
    This patent protects lyophilized daptomycin formulations with improved reconstitution times, which can include various additives.
    USPTO title: Daptomycin formulations and uses thereof
  • US10357535 Method of Use · expires 2033-09-11
    This patent protects improved lyophilized daptomycin formulations with additives for faster reconstitution and methods for preparing and using them to treat bacterial infections and biofilms.
    USPTO title: Daptomycin formulations and uses thereof

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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