Generic competition · all medicines · read 12 November 2026
Is there a generic of Prednisolone Sodium Phosphate, and who makes it?
Prednisolone Sodium Phosphate appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 6 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 6.9 and 14.5 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.
- Prednisolone Sodium Phosphate appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 6 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 6.9 and 14.5 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.
Solution, Oral
Four or more generic makers listed
Brand listed as marketed: Pediapred. 5 generic makers with 10 generic products listed as marketed; the first generic approval is dated 14 December 2000.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Chartwell Rx Sciences Llc | 25 May 2004 | 1 |
| Pharmaceutical Assoc Inc | 25 April 2005 | 3 |
| Mission Pharmacal Co | 13 September 2010 | 1 |
| Edenbridge Pharmaceuticals Llc | 20 December 2016 | 4 |
| Amneal Pharmaceuticals Llc | 25 October 2022 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution/Drops, Ophthalmic
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 28 March 1983.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Bausch And Lomb Inc | 29 July 1994 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Orally Disintegrating, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Orapred Odt. No generic is listed as marketed (3 generic products listed as discontinued).
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Injectable, Injection
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.
Ointment, Ophthalmic, Otic
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.