Generic entry timeline

Xifaxan generics — when can they launch?

Xifaxan (rifaximin) · Bausch Health · 17 active US patents · 8 expired

Earliest patent expiry
2027-09-02
1 year remaining
Full patent estate to
2029-10-02
complete protection through 2029
FDA approval
—
Bausch Health

Where Xifaxan sits in the generic timeline

Imminent generic cliff: earliest active US patent for Xifaxan 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 — 16 patents
  • Composition of Matter — 1 patent

FDA U-codes carved out by Xifaxan 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-1707(no description)
U-2644(no description)
U-2643(no description)
U-3511(no description)
U-3706(no description)
U-1708(no description)
U-1481(no description)
U-1121(no description)
U-1562(no description)
U-1994(no description)
U-2579(no description)

Sample patent estate

Showing 6 of 17 active US patents. View full estate on the Xifaxan drug page →

  • US8193196 Composition of Matter · expires 2027-09-02
    This patent protects crystalline polymorphous forms of rifaximin, specifically rifaximin δ and rifaximin ε, and methods for producing them.
    USPTO title: Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
  • US8193196 Method of Use · expires 2027-09-02
    This patent protects crystalline polymorphous forms of rifaximin, specifically rifaximin δ and rifaximin ε, used in medicinal preparations.
    USPTO title: Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
  • US10765667 Method of Use · expires 2029-02-26
    This patent protects new methods and kits for treating irritable bowel syndrome (IBS) in specific populations, including females, older subjects, and non-white subjects.
    USPTO title: Methods for treating irritable bowel syndrome (IBS)
  • US10456384 Method of Use · expires 2029-02-26
    This patent protects new methods and kits for treating irritable bowel syndrome (IBS) in specific populations, including females, older subjects, and non-white subjects.
    USPTO title: Methods for treating irritable bowel syndrome (IBS)
  • US11564912 Method of Use · expires 2029-02-26
    This patent protects new methods and kits for treating irritable bowel syndrome (IBS) in specific populations, including females, older subjects, and non-white subjects.
    USPTO title: Methods for treating irritable bowel syndrome (IBS)
  • US11779571 Method of Use · expires 2029-02-26
    This patent protects new methods and kits for treating irritable bowel syndrome (IBS) in specific populations, including females, older subjects, and non-white subjects.
    USPTO title: Methods for treating irritable bowel syndrome (IBS)

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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