Generic entry timeline

Recorlev generics — when can they launch?

Recorlev (LEVOKETOCONAZOLE) · Strongbridge · 5 active US patents · 4 expired

Earliest patent expiry
2028-05-03
2 years remaining
Full patent estate to
2040-03-02
complete protection through 2040
FDA approval
2021
Strongbridge

Where Recorlev sits in the generic timeline

Imminent generic cliff: earliest active US patent for Recorlev 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 — 5 patents

FDA U-codes carved out by Recorlev 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-3283(no description)
U-3821(no description)
U-3282(no description)
U-4236(no description)

Sample patent estate

Showing 5 of 5 active US patents. View full estate on the Recorlev drug page →

  • US9918984 Method of Use · expires 2028-05-03
    Pharmaceutical compositions containing a specific ketoconazole enantiomer are useful for treating type 2 diabetes, hyperglycemia, and other conditions.
    USPTO title: Methods and compositions for treating diabetes, metabolic syndrome and other conditions
  • US11903940 Method of Use · expires 2040-03-02
    This patent protects a method of administering levoketoconazole, or a salt thereof, to a subject also being administered a MATE1 substrate or an OCT2 substrate.
    USPTO title: Methods of treating disease with levoketoconazole
  • US11278547 Method of Use · expires 2040-03-02
    This patent protects a method of administering levoketoconazole, or a salt thereof, to a subject also being administered a MATE1 substrate or an OCT2 substrate.
    USPTO title: Methods of treating disease with levoketoconazole
  • US11020393 Method of Use · expires 2040-03-02
    This patent protects a method of administering levoketoconazole, or a salt thereof, to a subject also being administered a MATE1 substrate or an OCT2 substrate.
    USPTO title: Methods of treating disease with levoketoconazole
  • US12377096 Method of Use · expires 2040-03-02
    This patent protects a method of administering levoketoconazole, or a salt thereof, to a subject also being administered a MATE1 substrate or an OCT2 substrate.
    USPTO title: Methods of treating disease with levoketoconazole

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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