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OmniRx › Tools › Generic competition check › Apremilast

Generic competition · all medicines · read 12 November 2026

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

Apremilast appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 5 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 6.9 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.
Apremilast2 dosage-form groups in the Orange Book
5generic makers listed
  1. Apremilast appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 5 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 6.9 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.

Tablet, Oral

Four or more generic makers listed

Brand listed as marketed: Otezla. 5 generic makers with 15 generic products listed as marketed; the first generic approval is dated 17 February 2021.

20102015202020252030203505brand 2014Alkem Laboratories Ltd, first approval 21 September 2021Shilpa Medicare Ltd, first approval 7 April 2023Annora Pharma Private Ltd, first approval 26 July 2023Mankind Pharma Ltd, first approval 7 February 2024Msn Laboratories Private Ltd, first approval 16 December 2024data datePatent 7427638 listed to expire 16 February 2028Patent 7427638*PED listed to expire 16 August 2028Patent 12576034 listed to expire 30 November 2033Patent 10092541 listed to expire 29 May 2034Patent 9872854 listed to expire 29 May 2034Patent 12576034*PED listed to expire 30 May 2034Patent 9872854*PED listed to expire 29 November 2034Patent 10092541*PED listed to expire 29 November 2034Exclusivity PED to 19 January 2027Exclusivity PED to 20 January 2027Exclusivity NPP to 25 April 2027Exclusivity PED to 25 October 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Alkem Laboratories Ltd21 September 20213
Shilpa Medicare Ltd7 April 20233
Annora Pharma Private Ltd26 July 20233
Mankind Pharma Ltd7 February 20243
Msn Laboratories Private Ltd16 December 20243

Patents and exclusivities still listed

  • 19 January 2027Exclusivity PED Otezla
  • 20 January 2027Exclusivity PED Otezla
  • 25 April 2027Exclusivity NPP Otezla
  • 25 October 2027Exclusivity PED Otezla
  • 16 February 2028Patent 7427638 drug substance
  • 16 August 2028Patent 7427638*PED
  • 30 November 2033Patent 12576034 drug product
  • 29 May 2034Patent 10092541
  • 29 May 2034Patent 9872854
  • 30 May 2034Patent 12576034*PED
  • 29 November 2034Patent 9872854*PED
  • 29 November 2034Patent 10092541*PED

Tablet, Extended Release, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Otezla Xr. No generic is listed as marketed.

20202025203020352040204501brand 2025data datePatent 7427638 listed to expire 16 February 2028Patent 10092541 listed to expire 29 May 2034Patent 11752129 listed to expire 27 May 2042Patent 12427136 listed to expire 27 May 2042Patent 11969409 listed to expire 27 May 2042Exclusivity PED to 19 January 2027Exclusivity PED to 20 January 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 19 January 2027Exclusivity PED Otezla Xr
  • 20 January 2027Exclusivity PED Otezla Xr
  • 16 February 2028Patent 7427638 drug substance
  • 29 May 2034Patent 10092541
  • 27 May 2042Patent 11752129 drug product
  • 27 May 2042Patent 12427136
  • 27 May 2042Patent 11969409 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.