Generic entry timeline

MIRDAMETINIB generics — when can they launch?

MIRDAMETINIB (MIRDAMETINIB) · · 57 active US patents · 0 expired

Earliest patent expiry
2041-02-17
15 years remaining
Full patent estate to
2044-10-10
complete protection through 2044
FDA approval
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Where MIRDAMETINIB sits in the generic timeline

Long-dated protection: earliest active US patent for MIRDAMETINIB extends to 2041 (~15 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 — 50 patents
  • Composition of Matter — 6 patents
  • Formulation — 1 patent

FDA U-codes carved out by MIRDAMETINIB 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-4130(no description)

Sample patent estate

Showing 6 of 57 active US patents. View full estate on the MIRDAMETINIB drug page →

  • US11066358 Composition of Matter · expires 2041-02-17
    This patent protects a crystalline composition of essentially pure Form IV of the drug substance MIRDAMETINIB and methods of using it to treat tumors, cancers, or Rasopathy disorders.
    USPTO title: Compositions of essentially pure form IV of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof
  • US11806321 Method of Use · expires 2041-02-17
    This patent protects a method of using mirdametinib to treat certain types of tumors or cancers, such as plexiform neurofibromas.
    USPTO title: Non-linear dosing of mirdametinib
  • US11453641 Method of Use · expires 2041-02-17
    This patent protects methods of treating a tumor, cancer, or Rasopathy disorder by administering a specific crystalline form of the drug mirdametinib.
    USPTO title: Methods of treating neurofibromatosis with N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide
  • US12090128 Method of Use · expires 2041-02-17
    This patent protects dispersible pharmaceutical compositions of the drug MIRDAMETINIB and their uses.
    USPTO title: Dispersible formulations of n-((r)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benazmide and uses thereof
  • US11806321 Method of Use · expires 2041-02-17
    This patent protects a method of using mirdametinib to treat certain types of tumors or cancers, such as plexiform neurofibromas.
    USPTO title: Non-linear dosing of mirdametinib
  • US11084780 Composition of Matter · expires 2041-02-17
    This patent protects crystalline forms of the MEK inhibitor MIRDAMETINIB and methods of using it to treat tumors, cancers, and Rasopathy disorders.
    USPTO title: Crystalline solids of MEK inhibitor N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof

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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