Generic entry timeline

Copiktra generics — when can they launch?

Copiktra (DUVELISIB) · Secura · 12 active US patents · 0 expired

Earliest patent expiry
2029-01-05
3 years remaining
Full patent estate to
2035-04-26
complete protection through 2035
FDA approval
2018
Secura

Where Copiktra sits in the generic timeline

Imminent generic cliff: earliest active US patent for Copiktra expires in 2029 (~3 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 — 6 patents
  • Composition of Matter — 4 patents
  • Formulation — 2 patents

FDA U-codes carved out by Copiktra 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-2413(no description)
U-2412(no description)

Sample patent estate

Showing 6 of 12 active US patents. View full estate on the Copiktra drug page →

  • US9216982 Method of Use · expires 2029-01-05
    This patent describes chemical entities that modulate PI3 kinase activity and methods of using them for treating diseases and conditions associated with PI3 kinase activity.
    USPTO title: Certain chemical entities, compositions and methods
  • US9216982 Method of Use · expires 2029-01-05
    This patent describes chemical entities that modulate PI3 kinase activity and methods of using them for treating diseases and conditions associated with PI3 kinase activity.
    USPTO title: Certain chemical entities, compositions and methods
  • US11312718 Formulation · expires 2032-01-10
    This patent describes formulations of a chemical compound and methods for preparing it, which modulates kinase activity, including PI3 kinase activity.
    USPTO title: Formulations of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one
  • US11312718 Formulation · expires 2032-01-10
    This patent describes formulations of a chemical compound and methods for preparing it, which modulates kinase activity, including PI3 kinase activity.
    USPTO title: Formulations of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one
  • US9840505 Method of Use · expires 2032-01-10
    This patent protects solid forms of a chemical compound and methods of using it to treat diseases and conditions associated with kinase activity.
    USPTO title: Solid forms of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1 (2H)-one and methods of use thereof
  • US9840505 Method of Use · expires 2032-01-10
    This patent protects solid forms of a chemical compound and methods of using it to treat diseases and conditions associated with kinase activity.
    USPTO title: Solid forms of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1 (2H)-one and methods of use 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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