Generic entry timeline

Ekterly generics — when can they launch?

Ekterly (SEBETRALSTAT) · Kalvista · 8 active US patents · 0 expired

Earliest patent expiry
2035-11-26
10 years remaining
Full patent estate to
2039-01-26
complete protection through 2039
FDA approval
2025
Kalvista

Where Ekterly sits in the generic timeline

Long-dated protection: earliest active US patent for Ekterly extends to 2035 (~10 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.

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 — 5 patents
  • Composition of Matter — 3 patents

FDA U-codes carved out by Ekterly 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-4223(no description)

Sample patent estate

Showing 6 of 8 active US patents. View full estate on the Ekterly drug page →

  • US10364238 Composition of Matter · expires 2035-11-26
    This patent protects compounds that inhibit plasma kallikrein activity, which are used in therapy for treating or preventing diseases or conditions where plasma kallikrein activity is implicated.
    USPTO title: N-((het) arylmethyl)-heteroaryl-carboxamides compounds as plasma kallikrein inhibitors
  • US11198691 Method of Use · expires 2035-11-26
    This patent protects compounds and their use in therapy, particularly for treating or preventing diseases related to plasma kallikrein activity.
    USPTO title: N-((het)arylmethyl)-heteroaryl-carboxamides compounds as kallikrein inhibitors
  • US11084809 Method of Use · expires 2035-11-26
    This patent protects compounds that inhibit kallikrein activity, which can be used in therapy for treating or preventing diseases or conditions associated with plasma kallikrein activity.
    USPTO title: N-((HET)arylmethyl)-heteroaryl-carboxamides compounds as kallikrein inhibitors
  • US10611758 Method of Use · expires 2035-11-26
    This patent protects compounds and their use in therapy, particularly for treating or preventing diseases related to plasma kallikrein activity.
    USPTO title: N-((het)arylmethyl)-heteroaryl-carboxamides compounds as kallikrein inhibitors
  • US11001578 Composition of Matter · expires 2035-11-26
    This patent protects compounds of formula (I) and their use in therapy, particularly as plasma kallikrein inhibitors.
    USPTO title: N-((HET)arylmethyl)-heteroaryl-carboxamides compounds as plasma kallikrein inhibitors
  • US11739068 Method of Use · expires 2037-06-23
    This patent protects new forms of a chemical compound and its salts, which can be used in pharmaceutical compositions for therapeutic purposes.
    USPTO title: Polymorphs of N-[(3-fluoro-4-methoxypyridin-2-yl)methyl]-3-(methoxymethyl)-1-({4-[(2-oxopyridin-1-yl)methyl]phenyl}methyl)pyrazole-4-carboxamide and salts 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.

Get generic entry alerts

Free Pharma CI alerts on Ekterly — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.

Subscribe free →