Generic competition · all medicines · read 12 November 2026
Is there a generic of Progesterone, and who makes it?
Progesterone appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 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 13.8 and 18.2 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.
- Progesterone appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 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 13.8 and 18.2 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.
Capsule, Oral
Four or more generic makers listed
Brand listed as marketed: Prometrium. 6 generic makers with 12 generic products listed as marketed; the first generic approval is dated 29 February 2012.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Sofgen Pharmaceuticals Llc | 28 September 2012 | 2 |
| Bionpharma Inc | 16 August 2013 | 2 |
| Dr Reddys Laboratories Inc | 28 February 2017 | 2 |
| Amneal Pharmaceuticals Of Ny Llc | 7 September 2017 | 2 |
| Xiromed Pharma Espana Sl | 20 October 2017 | 2 |
| Eugia Pharma Specialities Ltd | 26 October 2018 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Injectable, Injection
Four or more generic makers listed
Every brand product here is listed as discontinued. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 25 April 2001.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fresenius Kabi Usa Llc | 25 April 2001 | 1 |
| Hikma Farmaceutica (Portugal) Sa | 28 October 2010 | 1 |
| Eugia Pharma Specialities Ltd | 6 December 2018 | 1 |
| Xiromed Pharma Espana Sl | 5 January 2022 | 1 |
| Accord Healthcare Inc | 21 November 2023 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Insert, Vaginal
One to three generic makers listed
Brand listed as marketed: Endometrin. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 19 September 2025.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Xiromed Pharma Espana Sl | 19 September 2025 | 1 |
| Glenmark Pharmaceuticals Inc Usa | 8 April 2026 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Gel, Vaginal
Brand listed, no generic listed as marketed
Brand listed as marketed: Crinone. 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, Extended Release, Intrauterine
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.
System, 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.