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OmniRx › Tools › Generic competition check › Doxylamine Succinate; Pyridoxine Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Doxylamine Succinate; Pyridoxine Hydrochloride, and who makes it?

Doxylamine Succinate; Pyridoxine Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 3 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 between 3.4 and 5.3 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.
Doxylamine Succinate; Pyridoxine Hydrochloride2 dosage-form groups in the Orange Book
3generic makers listed
  1. Doxylamine Succinate; Pyridoxine Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 3 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 between 3.4 and 5.3 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, Delayed Release, Oral

One to three generic makers listed

Brand listed as marketed: Diclegis. 3 generic makers with 3 generic products listed as marketed; the first generic approval is dated 19 August 2016.

2010201520202025203003brand 2013Actavis Laboratories Fl Inc, first approval 19 August 2016Ph Health Ltd, first approval 6 December 2017Bionpharma Inc, first approval 4 August 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Actavis Laboratories Fl Inc19 August 20161
Ph Health Ltd6 December 20171
Bionpharma Inc4 August 20231

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Tablet, Extended Release, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Bonjesta. No generic is listed as marketed (1 generic product listed as discontinued).

2015202020252030203501brand 2016data datePatent 9937132 listed to expire 18 February 2033Patent 9375404 listed to expire 18 February 2033Patent 9526703 listed to expire 18 February 2033Patent 9089489 listed to expire 18 February 2033
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 18 February 2033Patent 9937132 drug product
  • 18 February 2033Patent 9375404 drug product
  • 18 February 2033Patent 9526703 drug product
  • 18 February 2033Patent 9089489 drug product

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.