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

Generic competition · all medicines · read 12 November 2026

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

Tasimelteon 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 8.9 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.
Tasimelteon2 dosage-form groups in the Orange Book
3generic makers listed
  1. Tasimelteon 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 8.9 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.

Capsule, Oral

One to three generic makers listed

Brand listed as marketed: Hetlioz. 3 generic makers with 3 generic products listed as marketed; the first generic approval is dated 12 December 2022.

2010201520202025203020352040204503brand 2014Teva Pharmaceuticals Usa Inc, first approval 12 December 2022Apotex Inc, first approval 20 December 2022Msn Laboratories Private Ltd, first approval 12 January 2023data datePatent 9539234 listed to expire 25 January 2033Patent 9855241 listed to expire 25 January 2033Patent RE46604 listed to expire 25 January 2033Patent 10149829 listed to expire 25 January 2033Patent 9060995 listed to expire 25 January 2033Patent 10449176 listed to expire 25 January 2033Patent 10945988 listed to expire 25 January 2033Patent 11633377 listed to expire 25 January 2033Patent 10610510 listed to expire 25 January 2033Patent 12201604 listed to expire 25 January 2033Patent 10980770 listed to expire 25 January 2033Patent 11850229 listed to expire 25 January 2033Patent 11833130 listed to expire 25 January 2033Patent 11918557 listed to expire 25 January 2033Patent 11826339 listed to expire 25 January 2033Patent 11285129 listed to expire 25 January 2033Patent 9549913 listed to expire 25 January 2033Patent 11918556 listed to expire 7 April 2033Patent 9730910 listed to expire 17 May 2034Patent 11141400 listed to expire 10 October 2034Patent 10610511 listed to expire 10 October 2034Patent 11786502 listed to expire 10 October 2034Patent 11566011 listed to expire 12 February 2035Patent 12049457 listed to expire 12 February 2035Patent 10829465 listed to expire 12 February 2035Patent 11760740 listed to expire 12 February 2035Patent 10071977 listed to expire 12 February 2035Patent 10376487 listed to expire 27 July 2035Patent 11266622 listed to expire 29 August 2035Patent 10179119 listed to expire 29 August 2035Patent 11759446 listed to expire 21 February 2041Exclusivity ODE-330 to 1 December 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Teva Pharmaceuticals Usa Inc12 December 20221
Apotex Inc20 December 20221
Msn Laboratories Private Ltd12 January 20231

Patents and exclusivities still listed

  • 1 December 2027Exclusivity ODE-330 Hetlioz
  • 25 January 2033Patent 9539234
  • 25 January 2033Patent 9855241
  • 25 January 2033Patent RE46604
  • 25 January 2033Patent 10149829
  • 25 January 2033Patent 9060995
  • 25 January 2033Patent 10449176
  • 25 January 2033Patent 10945988
  • 25 January 2033Patent 11633377

23 more patents are listed.

Suspension, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Hetlioz Lq. No generic is listed as marketed.

20202025203020352040204501brand 2020data datePatent 10980770 listed to expire 25 January 2033Patent 11633377 listed to expire 25 January 2033Patent 10149829 listed to expire 25 January 2033Patent 9539234 listed to expire 25 January 2033Patent 10610510 listed to expire 25 January 2033Patent 12201604 listed to expire 25 January 2033Patent 11833130 listed to expire 25 January 2033Patent 11850229 listed to expire 25 January 2033Patent 11826339 listed to expire 25 January 2033Patent 11918557 listed to expire 25 January 2033Patent 11285129 listed to expire 25 January 2033Patent 11918556 listed to expire 7 April 2033Patent 9730910 listed to expire 17 May 2034Patent 11141400 listed to expire 10 October 2034Patent 10610511 listed to expire 10 October 2034Patent 11786502 listed to expire 10 October 2034Patent 12049457 listed to expire 12 February 2035Patent 10829465 listed to expire 12 February 2035Patent 10071977 listed to expire 12 February 2035Patent 11566011 listed to expire 12 February 2035Patent 11760740 listed to expire 12 February 2035Patent 10376487 listed to expire 27 July 2035Patent 11266622 listed to expire 29 August 2035Patent 10179119 listed to expire 29 August 2035Patent 12447141 listed to expire 11 December 2040Patent 11202770 listed to expire 11 December 2040Patent 11759446 listed to expire 21 February 2041Exclusivity ODE-329 to 1 December 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 1 December 2027Exclusivity ODE-329 Hetlioz Lq
  • 25 January 2033Patent 10980770
  • 25 January 2033Patent 11633377
  • 25 January 2033Patent 10149829
  • 25 January 2033Patent 9539234
  • 25 January 2033Patent 10610510
  • 25 January 2033Patent 12201604
  • 25 January 2033Patent 11833130
  • 25 January 2033Patent 11850229

19 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.