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Generic competition · all medicines · read 12 November 2026

Is there a generic of Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate, and who makes it?

Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 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. 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.
Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate1 dosage-form group in the Orange Book
0generic makers listed
  1. Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  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. 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.

Solution, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2020data datePatent 10675258 listed to expire 11 January 2033Patent 9132107 listed to expire 11 January 2033Patent 8901173 listed to expire 11 January 2033Patent 10195168 listed to expire 11 January 2033Patent 8591922 listed to expire 11 January 2033Patent 11554102 listed to expire 11 January 2033Patent 8772306 listed to expire 15 March 2033Patent 11986446 listed to expire 15 March 2033Patent 9050302 listed to expire 15 March 2033Patent 10213400 listed to expire 15 March 2033Patent 9486426 listed to expire 15 March 2033Patent 10864181 listed to expire 15 March 2033Patent 11253494 listed to expire 15 March 2033Patent 10213400*PED listed to expire 15 September 2033Patent 11253494*PED listed to expire 15 September 2033Patent 9050302*PED listed to expire 15 September 2033Patent 9486426*PED listed to expire 15 September 2033Patent 8772306*PED listed to expire 15 September 2033Patent 10864181*PED listed to expire 15 September 2033Patent 11426373 listed to expire 19 September 2037Patent 12138233 listed to expire 22 February 2041Patent 12582622 listed to expire 22 February 2041Exclusivity ODE-361 to 21 July 2027Exclusivity PED to 21 January 2028Exclusivity ODE-369 to 12 August 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 21 July 2027Exclusivity ODE-361 Xywav
  • 21 January 2028Exclusivity PED Xywav
  • 12 August 2028Exclusivity ODE-369 Xywav
  • 11 January 2033Patent 10675258
  • 11 January 2033Patent 9132107 drug product
  • 11 January 2033Patent 8901173 drug product
  • 11 January 2033Patent 10195168 drug product
  • 11 January 2033Patent 8591922 drug product
  • 11 January 2033Patent 11554102 drug product
  • 15 March 2033Patent 8772306
  • 15 March 2033Patent 11986446

14 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.