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OmniRx › Tools › Generic competition check › Neratinib Maleate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Neratinib Maleate, and who makes it?

Neratinib Maleate appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Neratinib Maleate1 dosage-form group in the Orange Book
0generic makers listed
  1. Neratinib Maleate appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Tablet, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Nerlynx. No generic is listed as marketed.

2015202020252030203501brand 2017data datePatent 10035788 listed to expire 15 October 2028Patent 9630946 listed to expire 15 October 2028Patent 9139558 listed to expire 15 October 2028Patent 9265784 listed to expire 4 August 2029Patent 9211291 listed to expire 24 March 2030Patent 8790708 listed to expire 5 November 2030Patent 8518446 listed to expire 20 November 2030Patent 7399865 listed to expire 29 December 2030Patent 8669273 listed to expire 18 July 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 15 October 2028Patent 10035788
  • 15 October 2028Patent 9630946
  • 15 October 2028Patent 9139558
  • 4 August 2029Patent 9265784
  • 24 March 2030Patent 9211291
  • 5 November 2030Patent 8790708 drug product
  • 20 November 2030Patent 8518446 drug product
  • 29 December 2030Patent 7399865 drug substance

1 more patents are listed.

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.