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OmniRx › Tools › Generic competition check › Dexmedetomidine Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Dexmedetomidine Hydrochloride, and who makes it?

Dexmedetomidine Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 23 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 8.9 and 14.7 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.
Dexmedetomidine Hydrochloride3 dosage-form groups in the Orange Book
23generic makers listed
  1. Dexmedetomidine Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 23 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 8.9 and 14.7 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.

Injectable, Injection

Four or more generic makers listed

Brand listed as marketed: Precedex. 22 generic makers with 45 generic products listed as marketed; the first generic approval is dated 18 August 2014.

199520002005201020152020202520302035022brand 1999Mylan Institutional Llc, first approval 18 August 2014Ph Health Ltd, first approval 18 August 2014Rising Pharma Holdings Inc, first approval 24 November 2014Gland Pharma Ltd, first approval 20 August 2015Fresenius Kabi Usa Llc, first approval 18 September 2015Accord Healthcare Inc, first approval 9 February 2016Eugia Pharma Specialities Ltd, first approval 17 March 2016Actavis Inc, first approval 17 October 2016Hikma Pharmaceuticals Usa Inc, first approval 26 April 2017Teva Pharmaceuticals Usa, first approval 28 November 2017Zydus Pharmaceuticals Usa Inc, first approval 27 February 2018Baxter Healthcare Corp, first approval 21 August 2018Meitheal Pharmaceuticals Inc, first approval 18 January 2019Wilshire Pharmaceuticals Inc, first approval 4 December 2019Amneal Pharmaceuticals Co Gmbh, first approval 20 May 2020Jiangsu Hengrui Pharmaceuticals Co Ltd, first approval 12 June 2020Mylan Laboratories Ltd, first approval 27 August 2020Tagi Pharma Inc, first approval 23 November 2020Amneal Eu Ltd, first approval 15 May 2023Milla Pharmaceuticals Inc, first approval 7 June 2023Dr Reddys Laboratories Ltd, first approval 25 February 2026Nephron Pharmaceuticals Corporation, first approval 28 September 2026data datePatent 8455527 listed to expire 4 January 2032Patent 9616049 listed to expire 4 January 2032Patent 8242158 listed to expire 4 January 2032Patent 8338470 listed to expire 4 January 2032Patent 9320712 listed to expire 4 January 2032Patent 8648106 listed to expire 4 January 2032Patent 10016396 listed to expire 4 January 2032Patent 8648106*PED listed to expire 4 July 2032Patent 8242158*PED listed to expire 4 July 2032Patent 8455527*PED listed to expire 4 July 2032Patent 8338470*PED listed to expire 4 July 2032Patent 9320712*PED listed to expire 4 July 2032Patent 9616049*PED listed to expire 4 July 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Mylan Institutional Llc18 August 20141
Ph Health Ltd18 August 20143
Rising Pharma Holdings Inc24 November 20141
Gland Pharma Ltd20 August 20153
Fresenius Kabi Usa Llc18 September 20154
Accord Healthcare Inc9 February 20161
Eugia Pharma Specialities Ltd17 March 20163
Actavis Inc17 October 20161
Hikma Pharmaceuticals Usa Inc26 April 20174
Teva Pharmaceuticals Usa28 November 20171
Zydus Pharmaceuticals Usa Inc27 February 20181
Baxter Healthcare Corp21 August 20182

10 more makers are listed in the data.

Patents and exclusivities still listed

  • 4 January 2032Patent 8455527
  • 4 January 2032Patent 9616049 drug product
  • 4 January 2032Patent 8242158 drug product
  • 4 January 2032Patent 8338470 drug product
  • 4 January 2032Patent 9320712 drug product
  • 4 January 2032Patent 8648106 drug product
  • 4 January 2032Patent 10016396 drug product
  • 4 July 2032Patent 8648106*PED

5 more patents are listed.

Solution, Intravenous

One to three generic makers listed

Brand listed as marketed: Dexmedetomidine Hydrochloride. 1 generic maker with 2 generic products listed as marketed; the first generic approval is dated 24 September 2024.

20152020202520302035204001brand 2015Somerset Therapeutics Llc, first approval 24 September 2024data datePatent 9717796 listed to expire 20 April 2036Patent 9649296 listed to expire 20 April 2036
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Somerset Therapeutics Llc24 September 20242

Patents and exclusivities still listed

  • 20 April 2036Patent 9717796 drug product
  • 20 April 2036Patent 9649296 drug product

Film, Buccal, Sublingual

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2022data datePatent 11786508 listed to expire 29 December 2037Patent 11839604 listed to expire 29 December 2037Patent 10792246 listed to expire 26 June 2039Patent 11517524 listed to expire 26 June 2039Patent 11497711 listed to expire 26 June 2039Patent 11478422 listed to expire 26 June 2039Patent 11998529 listed to expire 17 July 2040Patent 12109196 listed to expire 17 July 2040Patent 11890272 listed to expire 17 July 2040Patent 12364683 listed to expire 12 January 2043Patent 11998528 listed to expire 12 January 2043Patent 11806334 listed to expire 12 January 2043Patent 12090140 listed to expire 12 January 2043Patent 12138247 listed to expire 12 January 2043Exclusivity M-82 to 19 November 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 19 November 2028Exclusivity M-82 Igalmi
  • 29 December 2037Patent 11786508
  • 29 December 2037Patent 11839604
  • 26 June 2039Patent 10792246 drug product
  • 26 June 2039Patent 11517524 drug product
  • 26 June 2039Patent 11497711 drug product
  • 26 June 2039Patent 11478422 drug product
  • 17 July 2040Patent 11998529
  • 17 July 2040Patent 12109196

6 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.