interaction records 54 assistance programs 55 0 personal data stored
OmniRx › Tools › Generic competition check › Sodium Oxybate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Sodium Oxybate, and who makes it?

Sodium Oxybate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 2 generic makers 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 14.5 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.
Sodium Oxybate2 dosage-form groups in the Orange Book
2generic makers listed
  1. Sodium Oxybate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 2 generic makers 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 14.5 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.

For Suspension, Extended Release, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2023data datePatent 12303478 listed to expire 21 July 2037Patent 11602513 listed to expire 21 July 2037Patent 11602512 listed to expire 21 July 2037Patent 11400065 listed to expire 21 July 2037Patent 11000498 listed to expire 21 July 2037Patent 12128021 listed to expire 21 July 2037Patent 11986451 listed to expire 21 July 2037Patent 10952986 listed to expire 21 July 2037Patent 12097176 listed to expire 21 July 2037Patent 11896572 listed to expire 21 July 2037Patent 10272062 listed to expire 21 July 2037Patent 11504347 listed to expire 21 July 2037Patent 12109186 listed to expire 21 July 2037Patent 11839597 listed to expire 21 July 2037Patent 12097175 listed to expire 21 July 2037Patent 12115144 listed to expire 21 July 2037Patent 12144793 listed to expire 21 July 2037Patent 11052061 listed to expire 21 July 2037Patent 12115143 listed to expire 21 July 2037Patent 12115142 listed to expire 21 July 2037Patent 11065224 listed to expire 21 July 2037Patent 12138239 listed to expire 21 July 2037Patent 10973795 listed to expire 21 July 2037Patent 11766418 listed to expire 21 July 2037Patent 12115145 listed to expire 21 July 2037Patent 10736866 listed to expire 21 July 2037Patent 12728110 listed to expire 21 July 2037Patent 11826335 listed to expire 21 July 2037Patent 11583510 listed to expire 7 February 2042Patent 11779557 listed to expire 16 March 2042Exclusivity ODE-431 to 1 May 2030Exclusivity ODE-494 to 16 October 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 1 May 2030Exclusivity ODE-431 Lumryz
  • 16 October 2031Exclusivity ODE-494 Lumryz
  • 21 July 2037Patent 12303478
  • 21 July 2037Patent 11602513
  • 21 July 2037Patent 11602512
  • 21 July 2037Patent 11400065
  • 21 July 2037Patent 11000498 drug product
  • 21 July 2037Patent 12128021
  • 21 July 2037Patent 11986451
  • 21 July 2037Patent 10952986

22 more patents are listed.

Solution, Oral

One to three generic makers listed

Brand listed as marketed: Xyrem. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 17 January 2017.

2000200520102015202020252030203502brand 2002Amneal Pharmaceuticals Llc, first approval 10 September 2025Ascent Pharmaceuticals Inc, first approval 5 November 2025data datePatent 10213400 listed to expire 15 March 2033Patent 9486426 listed to expire 15 March 2033Patent 9050302 listed to expire 15 March 2033Patent 8772306 listed to expire 15 March 2033Patent 11986446 listed to expire 15 March 2033Patent 10864181 listed to expire 15 March 2033Patent 11253494 listed to expire 15 March 2033Patent 8772306*PED listed to expire 15 September 2033Patent 9486426*PED listed to expire 15 September 2033Patent 9050302*PED listed to expire 15 September 2033Patent 11253494*PED listed to expire 15 September 2033Patent 10213400*PED listed to expire 15 September 2033Patent 10864181*PED listed to expire 15 September 2033
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Amneal Pharmaceuticals Llc10 September 20251
Ascent Pharmaceuticals Inc5 November 20251

Patents and exclusivities still listed

  • 15 March 2033Patent 10213400
  • 15 March 2033Patent 9486426
  • 15 March 2033Patent 9050302
  • 15 March 2033Patent 8772306
  • 15 March 2033Patent 11986446
  • 15 March 2033Patent 10864181
  • 15 March 2033Patent 11253494
  • 15 September 2033Patent 8772306*PED

5 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.