Generic entry timeline

Inrebic generics — when can they launch?

Inrebic (FEDRATINIB HYDROCHLORIDE) · Bristol-Myers Squibb · 5 active US patents · 0 expired

Earliest patent expiry
2026-12-16
1 year remaining
Full patent estate to
2039-09-24
complete protection through 2039
FDA approval
2019
Bristol-Myers Squibb

Where Inrebic sits in the generic timeline

Imminent generic cliff: earliest active US patent for Inrebic expires in 2026 (~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 — 3 patents
  • Composition of Matter — 2 patents

FDA U-codes carved out by Inrebic 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-2607(no description)
U-3409(no description)

Sample patent estate

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

  • US7825246 Composition of Matter · expires 2026-12-16
    This patent protects biaryl meta-pyrimidine compounds that inhibit kinases, such as members of the Jak kinase family.
    USPTO title: Bi-aryl meta-pyrimidine inhibitors of kinases
  • US8138199 Method of Use · expires 2028-06-30
    This patent protects the use of biaryl meta-pyrimidine compounds that inhibit kinases, such as Jak kinase family members.
    USPTO title: Use of bi-aryl meta-pyrimidine inhibitors of kinases
  • US7528143 Composition of Matter · expires 2031-11-16
    This patent protects biaryl meta-pyrimidine compounds that inhibit kinases, such as members of the Jak kinase family.
    USPTO title: Bi-aryl meta-pyrimidine inhibitors of kinases
  • US10391094 Method of Use · expires 2032-06-04
    This patent protects compositions and methods for treating myelofibrosis in a subject using the compound Inrebic.
    USPTO title: Compositions and methods for treating myelofibrosis
  • US11400092 Method of Use · expires 2039-09-24
    This patent protects methods of treating myeloproliferative disorders by mitigating thiamine deficiency.
    USPTO title: Methods of treating myeloproliferative disorders

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 Inrebic — 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 →