Generic entry timeline

Xolremdi generics — when can they launch?

Xolremdi (MAVORIXAFOR) · X4 Pharms · 6 active US patents · 0 expired

Earliest patent expiry
2036-12-14
11 years remaining
Full patent estate to
2038-12-11
complete protection through 2038
FDA approval
2024
X4 Pharms

Where Xolremdi sits in the generic timeline

Long-dated protection: earliest active US patent for Xolremdi extends to 2036 (~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.

  • Formulation — 4 patents
  • Method of Use — 2 patents

FDA U-codes carved out by Xolremdi 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-3932(no description)

Sample patent estate

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

  • US10953003 Formulation · expires 2036-12-14
    This patent protects methods for treating advanced forms of cancer, such as clear cell renal cell carcinoma, using X4P-001.
    USPTO title: Methods for treating cancer
  • US11219621 Method of Use · expires 2036-12-22
    This patent protects methods of treating WHIM syndrome or related disorders by administering X4P-001 to reduce CXCR4 activity.
    USPTO title: Methods for treating immunodeficiency disease
  • US10610527 Method of Use · expires 2036-12-22
    This patent protects methods of treating WHIM syndrome or related disorders by administering X4P-001 to reduce CXCR4 activity.
    USPTO title: Methods for treating immunodeficiency disease
  • US10548889 Formulation · expires 2038-12-11
    This patent protects compositions and methods of use for treating, preventing, or ameliorating diseases associated with the CXCR4 chemokine receptor.
    USPTO title: Compositions of CXCR4 inhibitors and methods of preparation and use
  • US12115156 Formulation · expires 2038-12-11
    This patent protects compositions and methods of use for treating, preventing, or ameliorating diseases associated with the CXCR4 chemokine receptor.
    USPTO title: Compositions of CXCR4 inhibitors and methods of preparation and use
  • US11045461 Formulation · expires 2038-12-11
    This patent protects compositions and methods of use for treating, preventing, or ameliorating diseases associated with the CXCR4 chemokine receptor.
    USPTO title: Compositions of CXCR4 inhibitors and methods of preparation and use

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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