Generic entry timeline

NERATINIB MALEATE generics — when can they launch?

NERATINIB MALEATE (NERATINIB MALEATE) · · 9 active US patents · 0 expired

Earliest patent expiry
2028-10-15
2 years remaining
Full patent estate to
2031-07-18
complete protection through 2031
FDA approval
2017
—

Where NERATINIB MALEATE sits in the generic timeline

Imminent generic cliff: earliest active US patent for NERATINIB MALEATE expires in 2028 (~2 years 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 — 8 patents
  • Composition of Matter — 1 patent

FDA U-codes carved out by NERATINIB MALEATE 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-2043(no description)
U-3097(no description)
U-3047(no description)

Sample patent estate

Showing 6 of 9 active US patents. View full estate on the NERATINIB MALEATE drug page →

  • US10035788 Method of Use · expires 2028-10-15
    This patent protects maleate salt forms of a specific compound used to treat cancers, particularly those affected by kinases of the epidermal growth factor receptor family.
    USPTO title: Maleate salts of (E)-N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
  • US9139558 Method of Use · expires 2028-10-15
    This patent protects maleate salt forms of a specific compound used to treat cancers, particularly those affected by kinases of the epidermal growth factor receptor family.
    USPTO title: Maleate salts of (E)-N-{4-[3-Chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
  • US9630946 Method of Use · expires 2028-10-15
    This patent protects maleate salt forms of a specific compound used to treat cancers, particularly those affected by kinases of the epidermal growth factor receptor family.
    USPTO title: Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
  • US9265784 Method of Use · expires 2029-08-04
    This patent protects a combination of a 4-anilino-3-cyanoquinoline compound and a capecitabine compound for treating various types of cancer.
    USPTO title: Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine
  • US9211291 Method of Use · expires 2030-03-24
    This patent protects an extended treatment regimen for HER-2/neu overexpressed/amplified cancer patients using neratinib therapy.
    USPTO title: Treatment regimen utilizing neratinib for breast cancer
  • US8790708 Method of Use · expires 2030-11-05
    This patent protects coated tablet formulations of neratinib maleate and methods for making such tablets.
    USPTO title: Coated tablet formulations 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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