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Generic competition · all medicines · read 12 November 2026

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

Enzalutamide appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 1 generic maker listed as marketed across them. 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. Where both are dated, the first generic approval came between 5.7 and 8.7 years after the first brand approval. 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.
Enzalutamide2 dosage-form groups in the Orange Book
1generic maker listed
  1. Enzalutamide appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 1 generic maker listed as marketed across them.
  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. Where both are dated, the first generic approval came between 5.7 and 8.7 years after the first brand approval.
  4. 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.

Capsule, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Xtandi. No generic is listed as marketed (3 generic products listed as discontinued).

201020152020202520302035204001brand 2012data datePatent 7709517 listed to expire 13 August 2027Patent 12161628 listed to expire 23 February 2037Exclusivity I-926 to 17 November 2026
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 17 November 2026Exclusivity I-926 Xtandi
  • 13 August 2027Patent 7709517 drug substance
  • 23 February 2037Patent 12161628

Tablet, Oral

One to three generic makers listed

Brand listed as marketed: Xtandi. 1 generic maker with 2 generic products listed as marketed; the first generic approval is dated 20 April 2026.

2020202520302035204001brand 2020Sandoz Inc, first approval 20 April 2026data datePatent 7709517 listed to expire 13 August 2027Patent 12502357 listed to expire 11 September 2033Patent 11839689 listed to expire 11 September 2033Patent 12447128 listed to expire 11 September 2033Patent 12161628 listed to expire 23 February 2037Exclusivity I-926 to 17 November 2026
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sandoz Inc20 April 20262

Patents and exclusivities still listed

  • 17 November 2026Exclusivity I-926 Xtandi
  • 13 August 2027Patent 7709517 drug substance
  • 11 September 2033Patent 12502357
  • 11 September 2033Patent 11839689 drug product
  • 11 September 2033Patent 12447128
  • 23 February 2037Patent 12161628

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.