Generic entry timeline

ESKETAMINE HYDROCHLORIDE generics — when can they launch?

ESKETAMINE HYDROCHLORIDE (ESKETAMINE HYDROCHLORIDE) · · 7 active US patents · 0 expired

Earliest patent expiry
2027-03-20
1 year remaining
Full patent estate to
2040-02-18
complete protection through 2040
FDA approval
2019
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Where ESKETAMINE HYDROCHLORIDE sits in the generic timeline

Imminent generic cliff: earliest active US patent for ESKETAMINE HYDROCHLORIDE expires in 2027 (~1 year 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

FDA U-codes carved out by ESKETAMINE HYDROCHLORIDE 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-2502(no description)
U-4118(no description)
U-4113(no description)
U-4116(no description)
U-4115(no description)
U-4120(no description)

Sample patent estate

Showing 6 of 7 active US patents. View full estate on the ESKETAMINE HYDROCHLORIDE drug page →

  • US9592207 Method of Use · expires 2027-03-20
    This patent protects a method of using intranasal administration of ketamine to treat treatment-resistant depression.
    USPTO title: Intranasal administration of ketamine to treat depression
  • US8785500 Method of Use · expires 2033-03-05
    This patent protects methods and compositions for treating treatment-resistant depression through intranasal administration of ketamine.
    USPTO title: Intranasal administration of ketamine to treat depression
  • US11446260 Method of Use · expires 2034-03-14
    This patent protects an aqueous formulation of S-ketamine hydrochloride for nasal administration without an antimicrobial preservative.
    USPTO title: Pharmaceutical composition of S-ketamine hydrochloride
  • US10869844 Method of Use · expires 2035-09-10
    This patent protects methods and dosing regimens for treating depression, particularly treatment-resistant depression and suicidality.
    USPTO title: Methods for the treatment of depression
  • US11311500 Method of Use · expires 2035-09-10
    This patent protects methods and dosing regimens for treating depression, particularly treatment-resistant depression and suicidality.
    USPTO title: Methods for the treatment of depression
  • US11173134 Method of Use · expires 2035-09-10
    This patent protects methods and dosing regimens for treating depression, particularly treatment-resistant depression and suicidality.
    USPTO title: Methods for the treatment of depression

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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