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Generic competition · all medicines · read 12 November 2026

Is there a generic of Larotrectinib Sulfate, and who makes it?

Larotrectinib Sulfate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 2 groups have 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.
Larotrectinib Sulfate2 dosage-form groups in the Orange Book
0generic makers listed
  1. Larotrectinib Sulfate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  2. 2 groups have 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.

Capsule, Oral

Brand listed, no generic listed as marketed

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

20152020202520302035204001brand 2018data datePatent 10047097 listed to expire 21 October 2029Patent 8865698 listed to expire 21 October 2029Patent 10005783 listed to expire 21 October 2029Patent 9447104 listed to expire 21 October 2029Patent 9676783 listed to expire 21 October 2029Patent 10774085 listed to expire 21 October 2029Patent 9127013 listed to expire 21 October 2029Patent 8513263 listed to expire 23 December 2029Patent 9782414 listed to expire 16 November 2035Patent 10285993 listed to expire 16 November 2035Patent 10813936 listed to expire 16 November 2035Patent 10172861 listed to expire 16 November 2035Patent 10799505 listed to expire 15 August 2036Patent 11974998 listed to expire 16 May 2037Patent 11337967 listed to expire 16 May 2037
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 21 October 2029Patent 10047097
  • 21 October 2029Patent 8865698
  • 21 October 2029Patent 10005783
  • 21 October 2029Patent 9447104
  • 21 October 2029Patent 9676783
  • 21 October 2029Patent 10774085
  • 21 October 2029Patent 9127013 drug substance
  • 23 December 2029Patent 8513263 drug substance

7 more patents are listed.

Solution, Oral

Brand listed, no generic listed as marketed

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

20152020202520302035204001brand 2018data datePatent 10047097 listed to expire 21 October 2029Patent 8865698 listed to expire 21 October 2029Patent 10005783 listed to expire 21 October 2029Patent 9447104 listed to expire 21 October 2029Patent 9676783 listed to expire 21 October 2029Patent 10774085 listed to expire 21 October 2029Patent 9127013 listed to expire 21 October 2029Patent 8513263 listed to expire 23 December 2029Patent 9782414 listed to expire 16 November 2035Patent 10172861 listed to expire 16 November 2035Patent 10799505 listed to expire 15 August 2036Patent 10045991 listed to expire 4 April 2037Patent 11484535 listed to expire 4 April 2037Patent 11191766 listed to expire 4 April 2037Patent 10668072 listed to expire 4 April 2037Patent 10137127 listed to expire 4 April 2037Patent 11337967 listed to expire 16 May 2037Patent 11974998 listed to expire 16 May 2037
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 21 October 2029Patent 10047097
  • 21 October 2029Patent 8865698
  • 21 October 2029Patent 10005783
  • 21 October 2029Patent 9447104
  • 21 October 2029Patent 9676783
  • 21 October 2029Patent 10774085
  • 21 October 2029Patent 9127013 drug substance
  • 23 December 2029Patent 8513263 drug substance

10 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.