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Generic competition · all medicines · read 12 November 2026

Is there a generic of Fluticasone Propionate; Salmeterol Xinafoate, and who makes it?

Fluticasone Propionate; Salmeterol Xinafoate 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 18.4 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.
Fluticasone Propionate; Salmeterol Xinafoate2 dosage-form groups in the Orange Book
5generic makers listed
  1. Fluticasone Propionate; Salmeterol Xinafoate 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 18.4 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.

Powder, Inhalation

Four or more generic makers listed

Brand listed as marketed: Advair Diskus 100/50, Advair Diskus 250/50, Advair Diskus 500/50 and Airduo Respiclick. 5 generic makers with 14 generic products listed as marketed; the first generic approval is dated 30 January 2019.

20002005201020152020202520302035204005brand 2000Mylan Pharmaceuticals Inc, first approval 30 January 2019Hikma Pharmaceuticals Usa Inc, first approval 17 December 2020Teva Pharmaceuticals Usa Inc, first approval 13 December 2021Respirent Pharmaceuticals Co Ltd, first approval 12 January 2026Cipla Ltd, first approval 27 July 2026data datePatent 10195375 listed to expire 14 February 2031Patent 10195375*PED listed to expire 14 August 2031Patent 9415008 listed to expire 6 October 2034Patent 9066957 listed to expire 6 October 2034Patent 9415008*PED listed to expire 6 April 2035Patent 9066957*PED listed to expire 6 April 2035Patent 11969544 listed to expire 20 August 2039Patent 11969544*PED listed to expire 20 February 2040
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Mylan Pharmaceuticals Inc30 January 20193
Hikma Pharmaceuticals Usa Inc17 December 20203
Teva Pharmaceuticals Usa Inc13 December 20213
Respirent Pharmaceuticals Co Ltd12 January 20262
Cipla Ltd27 July 20263

Patents and exclusivities still listed

  • 14 February 2031Patent 10195375 drug product
  • 14 August 2031Patent 10195375*PED
  • 6 October 2034Patent 9415008 drug product
  • 6 October 2034Patent 9066957 drug product
  • 6 April 2035Patent 9415008*PED
  • 6 April 2035Patent 9066957*PED
  • 20 August 2039Patent 11969544 drug product
  • 20 February 2040Patent 11969544*PED

Aerosol, Metered, Inhalation

Brand listed, no generic listed as marketed

Brand listed as marketed: Advair Hfa. No generic is listed as marketed.

20052010201520202025203001brand 2006data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

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

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.