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OmniRx › Tools › Generic competition check › Baloxavir Marboxil

Generic competition · all medicines · read 12 November 2026

Is there a generic of Baloxavir Marboxil, and who makes it?

Baloxavir Marboxil 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 7.6 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.
Baloxavir Marboxil2 dosage-form groups in the Orange Book
1generic maker listed
  1. Baloxavir Marboxil 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 7.6 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.

Tablet, Oral

One to three generic makers listed

Brand listed as marketed: Xofluza. 1 generic maker with 2 generic products listed as marketed; the first generic approval is dated 17 June 2026.

20152020202520302035204001brand 2018Norwich Pharmaceuticals Inc, first approval 17 June 2026data datePatent 9815835 listed to expire 14 June 2030Patent 8927710 listed to expire 5 May 2031Patent 8987441 listed to expire 24 October 2032Patent 10633397 listed to expire 27 April 2036Patent 10392406 listed to expire 27 April 2036Patent 11306106 listed to expire 9 August 2037Patent 10759814 listed to expire 9 August 2037Patent 11261198 listed to expire 25 September 2038Patent 12064438 listed to expire 9 October 2039Exclusivity M-187 to 19 December 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Norwich Pharmaceuticals Inc17 June 20262

Patents and exclusivities still listed

  • 19 December 2027Exclusivity M-187 Xofluza
  • 14 June 2030Patent 9815835 drug product
  • 5 May 2031Patent 8927710 drug product
  • 24 October 2032Patent 8987441 drug substance
  • 27 April 2036Patent 10633397
  • 27 April 2036Patent 10392406 drug substance
  • 9 August 2037Patent 11306106
  • 9 August 2037Patent 10759814 drug substance
  • 25 September 2038Patent 11261198 drug product

1 more patents are listed.

For Suspension, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2020data datePatent 9815835 listed to expire 14 June 2030Patent 8927710 listed to expire 5 May 2031Patent 8987441 listed to expire 24 October 2032Patent 10633397 listed to expire 27 April 2036Patent 10392406 listed to expire 27 April 2036Patent 11306106 listed to expire 9 August 2037Patent 10759814 listed to expire 9 August 2037Patent 11261198 listed to expire 25 September 2038Patent 11925648 listed to expire 21 April 2041Exclusivity M-187 to 19 December 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 19 December 2027Exclusivity M-187 Xofluza
  • 14 June 2030Patent 9815835 drug product
  • 5 May 2031Patent 8927710 drug product
  • 24 October 2032Patent 8987441 drug substance
  • 27 April 2036Patent 10633397
  • 27 April 2036Patent 10392406 drug substance
  • 9 August 2037Patent 11306106
  • 9 August 2037Patent 10759814 drug substance
  • 25 September 2038Patent 11261198 drug product

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.