Generic competition · all medicines · read 12 November 2026
Is there a generic of Hydrocortisone, and who makes it?
Hydrocortisone appears in 13 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 17 generic makers listed as marketed across them. 2 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. 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.
- Hydrocortisone appears in 13 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 17 generic makers listed as marketed across them.
- 2 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.
- 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
Four or more generic makers listed
Every brand product here is listed as discontinued. 7 generic makers with 9 generic products listed as marketed; the first generic approval is dated 8 April 1982.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Padagis Us Llc | not dated | 1 |
| Actavis Mid Atlantic Llc | 3 May 1983 | 1 |
| Taro Pharmaceutical Industries Ltd | 9 November 1984 | 1 |
| Fougera Pharmaceuticals Inc | 16 December 1986 | 2 |
| Rising Pharma Holdings Inc | 20 August 2010 | 1 |
| Crown Laboratories Inc | 5 January 2016 | 2 |
| Encube Ethicals Private Ltd | 23 July 2018 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Oral
Four or more generic makers listed
Brand listed as marketed: Cortef. 6 generic makers with 18 generic products listed as marketed; the first generic approval is dated 31 August 1982.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Impax Laboratories Inc | 30 March 2007 | 3 |
| Strides Pharma Global Pte Ltd | 27 April 2017 | 3 |
| Aurobindo Pharma Ltd | 17 July 2023 | 3 |
| Adaptis Pharma Private Ltd | 25 November 2024 | 3 |
| Novitium Pharma Llc | 2 May 2025 | 3 |
| Appco Pharma Llc | 25 February 2026 | 3 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Lotion, Topical
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 7 June 1982.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Legacy Pharma Inc Sezc | not dated | 1 |
| Padagis Us Llc | 26 November 1985 | 1 |
| Rising Pharma Holdings Inc | 16 July 2026 | 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
Every brand product here is listed as discontinued. 3 generic makers with 4 generic products listed as marketed; the first generic approval is dated 13 October 1982.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Padagis Us Llc | not dated | 1 |
| Pharmobedient Consulting Llc | 6 September 1985 | 1 |
| Fougera Pharmaceuticals Inc | 28 May 1993 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Granule, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Alkindi Sprinkle. No generic is listed as marketed.
Patents and exclusivities still listed
- 19 November 2032Patent 9717740
- 10 January 2033Patent 9675559
- 12 May 2034Patent 9649280 drug product
Enema, Rectal
One to three generic makers listed
Brand listed as marketed: Cortenema. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 27 May 1994.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Chartwell Life Molecules Llc | 3 December 1999 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Powder, For Rx Compounding
Nothing listed as marketed
No brand application is listed. 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.
Solution, Topical
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 6 June 1984.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Mission Pharmacal Co | 17 April 1992 | 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
No brand application is listed. No generic is listed as marketed (2 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.
Aerosol, 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.
Injectable, Injection
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.
Solution, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Khindivi. No generic is listed as marketed.
Patents and exclusivities still listed
- 23 February 2043Patent 12133914
- 23 February 2043Patent 11904046 drug product
Tablet, Vaginal
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.