Generic competition · all medicines · read 12 November 2026
Is there a generic of Fluocinolone Acetonide, and who makes it?
Fluocinolone Acetonide appears in 8 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 12 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 5.9 and 23.7 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.
- Fluocinolone Acetonide appears in 8 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 12 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 5.9 and 23.7 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.
Cream, Topical
One to three generic makers listed
Brand listed as marketed: Synalar. 2 generic makers with 4 generic products listed as marketed; the first generic approval is dated 4 March 1982.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fougera Pharmaceuticals Inc | 16 December 1982 | 2 |
| Cosette Pharmaceuticals Nc Laboratories Llc | 26 July 1988 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Oil, Topical
Four or more generic makers listed
Brand listed as marketed: Derma-Smoothe/Fs. 5 generic makers with 10 generic products listed as marketed; the first generic approval is dated 17 October 2011.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Padagis Israel Pharmaceuticals Ltd | 9 August 2013 | 2 |
| Rising Pharma Holdings Inc | 25 April 2016 | 2 |
| Sun Pharma Canada Inc | 19 May 2016 | 2 |
| Quagen Pharmaceuticals Llc | 2 April 2021 | 2 |
| Novel Laboratories Inc | 31 July 2023 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Topical
Four or more generic makers listed
Brand listed as marketed: Synalar. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 16 June 1982.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fougera Pharmaceuticals Inc | 16 December 1982 | 1 |
| Sun Pharma Canada Inc | 11 September 1985 | 1 |
| Lupin Inc | 2 September 2015 | 1 |
| Chartwell Rx Sciences Llc | 26 December 2017 | 1 |
| Encube Ethicals Pvt Ltd | 13 February 2019 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Oil/Drops, Otic
Four or more generic makers listed
Brand listed as marketed: Dermotic. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 17 October 2011.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Rising Pharma Holdings Inc | 25 April 2016 | 1 |
| Padagis Israel Pharmaceuticals Ltd | 17 July 2017 | 1 |
| Anda Repository Llc | 11 April 2018 | 1 |
| Tp Anda Holdings Llc | 5 February 2021 | 1 |
| Quagen Pharmaceuticals Llc | 2 April 2021 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Ointment, Topical
One to three generic makers listed
Brand listed as marketed: Synalar. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 16 December 1982.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fougera Pharmaceuticals Inc | 16 December 1982 | 1 |
| Cosette Pharmaceuticals Nc Laboratories Llc | 26 July 1988 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Implant, Intravitreal
Brand listed, no generic listed as marketed
Brand listed as marketed: Iluvien. No generic is listed as marketed.
Patents and exclusivities still listed
- 12 August 2027Patent 8871241 drug product
- 7 November 2028Patent 9849027 drug product
Gel, Topical
Nothing listed as marketed
No brand application is listed. No generic is listed as marketed (1 generic product listed as discontinued).
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Shampoo, Topical
Nothing listed as marketed
Every brand product here is listed as discontinued. 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.