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.
- 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.
- 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.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Mylan Pharmaceuticals Inc | 30 January 2019 | 3 |
| Hikma Pharmaceuticals Usa Inc | 17 December 2020 | 3 |
| Teva Pharmaceuticals Usa Inc | 13 December 2021 | 3 |
| Respirent Pharmaceuticals Co Ltd | 12 January 2026 | 2 |
| Cipla Ltd | 27 July 2026 | 3 |
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.
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.