Generic competition · all medicines · read 12 November 2026
Is there a generic of Dexamethasone, and who makes it?
Dexamethasone appears in 10 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 14 generic makers listed as marketed across them. 3 groups have 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 0.7 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.
- Dexamethasone appears in 10 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 14 generic makers listed as marketed across them.
- 3 groups have 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 0.7 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.
Tablet, Oral
Four or more generic makers listed
Brand listed as marketed: Hemady. 11 generic makers with 47 generic products listed as marketed; the first generic approval is dated 28 April 1983.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Alvogen Inc | 28 April 1983 | 4 |
| Pangea Pharmaceuticals Llc | 28 April 1983 | 1 |
| Hikma Pharmaceuticals Usa Inc | 15 September 1983 | 7 |
| Pharmobedient Consulting Llc | 17 July 2017 | 1 |
| Amneal Eu Ltd | 14 October 2021 | 3 |
| Prasco Llc Dba Prasco Laboratories | 20 April 2022 | 1 |
| Novitium Pharma Llc | 8 August 2022 | 6 |
| Bionpharma Inc | 19 April 2023 | 3 |
| Apotex Inc | 23 August 2023 | 7 |
| Zydus Lifesciences Ltd | 7 February 2024 | 7 |
| Solgen Pharma Llc | 17 September 2024 | 7 |
Patents and exclusivities still listed
- 18 December 2037Patent 11304961 drug product
- 18 December 2037Patent 10537585 drug product
Elixir, Oral
One to three generic makers listed
Every brand product here is listed as discontinued. 3 generic makers with 3 generic products listed as marketed; the first generic approval is dated 27 July 1983.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Pharmazone | not dated | 1 |
| Chartwell Molecular Holdings Llc | 11 May 2011 | 1 |
| Rising Pharma Holdings Inc | 12 July 2011 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Aerosol, Topical
Nothing listed as marketed
Every brand product here is listed as discontinued. 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.
Suspension/Drops, Ophthalmic
Brand listed, no generic listed as marketed
Brand listed as marketed: Maxidex. 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.
Concentrate, Oral
Generics listed, no brand listed
No brand application is listed. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 1 September 1983.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hikma Pharmaceuticals Usa Inc | 1 September 1983 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Gel, 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.
Implant, Intravitreal
Brand listed, no generic listed as marketed
Brand listed as marketed: Ozurdex. 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.
Insert, Ophthalmic
Brand listed, no generic listed as marketed
Brand listed as marketed: Dextenza. No generic is listed as marketed.
Patents and exclusivities still listed
- 7 April 2028Exclusivity NPP Dextenza
- 12 February 2030Patent 8563027
- 14 May 2030Patent 8409606 drug product
- 7 October 2036Patent 12150896
- 16 November 2037Patent 11458041
- 26 April 2041Patent 12144889
Solution, Oral
Generics listed, no brand listed
No brand application is listed. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 1 September 1983.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hikma Pharmaceuticals Usa Inc | 1 September 1983 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Suspension, Intraocular
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.