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OmniRx › Tools › Generic competition check › Odevixibat

Generic competition · all medicines · read 12 November 2026

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

Odevixibat 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.
Odevixibat2 dosage-form groups in the Orange Book
0generic makers listed
  1. Odevixibat 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, Pellets, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2021data datePatent 12545705 listed to expire 8 November 2031Patent 10487111 listed to expire 8 November 2031Patent 10981952 listed to expire 8 November 2031Patent 10011633 listed to expire 8 November 2031Patent 10093697 listed to expire 8 November 2031Patent 11732006 listed to expire 8 November 2031Patent 12187812 listed to expire 8 November 2031Patent 9694018 listed to expire 18 March 2034Patent 12508234 listed to expire 20 June 2039Patent 11365182 listed to expire 20 June 2039Patent 11801226 listed to expire 20 June 2039Patent 12091394 listed to expire 20 June 2039Patent 11802115 listed to expire 20 June 2039Patent 10975046 listed to expire 20 June 2039Patent 12447156 listed to expire 12 November 2041Patent 11583539 listed to expire 12 November 2041Exclusivity ODE-363 to 20 July 2028Exclusivity ODE-436 to 13 June 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 20 July 2028Exclusivity ODE-363 Bylvay
  • 13 June 2030Exclusivity ODE-436 Bylvay
  • 8 November 2031Patent 12545705
  • 8 November 2031Patent 10487111
  • 8 November 2031Patent 10981952
  • 8 November 2031Patent 10011633
  • 8 November 2031Patent 10093697
  • 8 November 2031Patent 11732006
  • 8 November 2031Patent 12187812
  • 18 March 2034Patent 9694018

8 more patents are listed.

Capsule, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2021data datePatent 12545705 listed to expire 8 November 2031Patent 10981952 listed to expire 8 November 2031Patent 10487111 listed to expire 8 November 2031Patent 10093697 listed to expire 8 November 2031Patent 10011633 listed to expire 8 November 2031Patent 11732006 listed to expire 8 November 2031Patent 12187812 listed to expire 8 November 2031Patent 9694018 listed to expire 18 March 2034Patent 12508234 listed to expire 20 June 2039Patent 11365182 listed to expire 20 June 2039Patent 11802115 listed to expire 20 June 2039Patent 10975046 listed to expire 20 June 2039Patent 12091394 listed to expire 20 June 2039Patent 11801226 listed to expire 20 June 2039Patent 12447156 listed to expire 12 November 2041Patent 11583539 listed to expire 12 November 2041Exclusivity ODE-363 to 20 July 2028Exclusivity ODE-436 to 13 June 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 20 July 2028Exclusivity ODE-363 Bylvay
  • 13 June 2030Exclusivity ODE-436 Bylvay
  • 8 November 2031Patent 12545705
  • 8 November 2031Patent 10981952
  • 8 November 2031Patent 10487111
  • 8 November 2031Patent 10093697
  • 8 November 2031Patent 10011633
  • 8 November 2031Patent 11732006
  • 8 November 2031Patent 12187812
  • 18 March 2034Patent 9694018

8 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.