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OmniRx › Tools › Generic competition check › Darolutamide

Generic competition · all medicines · read 12 November 2026

Is there a generic of Darolutamide, and who makes it?

Darolutamide 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.
Darolutamide1 dosage-form group in the Orange Book
0generic makers listed
  1. Darolutamide 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: Nubeqa. No generic is listed as marketed.

201520202025203020352040204501brand 2019data datePatent 9657003 listed to expire 27 October 2030Patent 11046713 listed to expire 27 October 2030Patent 10711013 listed to expire 27 October 2030Patent 8975254 listed to expire 25 March 2033Patent 10835515 listed to expire 28 January 2036Patent 10010530 listed to expire 28 January 2036Patent 10383853 listed to expire 28 January 2036Patent 11168058 listed to expire 27 February 2038Patent 12611397 listed to expire 2 July 2040Patent 12329742 listed to expire 17 June 2042Exclusivity I-971 to 3 June 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 3 June 2028Exclusivity I-971 Nubeqa
  • 27 October 2030Patent 9657003 drug substance
  • 27 October 2030Patent 11046713 drug substance
  • 27 October 2030Patent 10711013 drug substance
  • 25 March 2033Patent 8975254 drug substance
  • 28 January 2036Patent 10835515 drug product
  • 28 January 2036Patent 10010530 drug substance
  • 28 January 2036Patent 10383853 drug substance
  • 27 February 2038Patent 11168058 drug substance

2 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.