Generic entry timeline

Iqirvo generics — when can they launch?

Iqirvo (ELAFIBRANOR) · Ipsen · 8 active US patents · 0 expired

Earliest patent expiry
2037-03-30
11 years remaining
Full patent estate to
2037-03-30
complete protection through 2037
FDA approval
2024
Ipsen

Where Iqirvo sits in the generic timeline

Long-dated protection: earliest active US patent for Iqirvo extends to 2037 (~11 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 — 8 patents

FDA U-codes carved out by Iqirvo 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-1854(no description)
U-3955(no description)

Sample patent estate

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

  • US12310935 Method of Use · expires 2037-03-30
    This patent protects the use of Elafibranor for treating cholestatic diseases, specifically Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).
    USPTO title: Methods of treatment of cholestatic diseases
  • US12233038 Method of Use · expires 2037-03-30
    This patent protects the use of Elafibranor for treating cholestatic diseases, specifically Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).
    USPTO title: Methods of treatment of cholestatic diseases
  • US11331292 Method of Use · expires 2037-03-30
    This patent protects the use of Elafibranor for treating cholestatic diseases, specifically Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).
    USPTO title: Methods of treatment of cholestatic diseases
  • US11185519 Method of Use · expires 2037-03-30
    This patent protects the use of Elafibranor for treating cholestatic diseases, specifically Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).
    USPTO title: Methods of treatment of cholestatic diseases
  • US11857523 Method of Use · expires 2037-03-30
    This patent protects the use of Elafibranor for treating cholestatic diseases, specifically Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).
    USPTO title: Methods of treatment of cholestatic diseases
  • US11850223 Method of Use · expires 2037-03-30
    This patent protects the use of Elafibranor for treating cholestatic diseases, specifically Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).
    USPTO title: Methods of treatment of cholestatic diseases

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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