Generic competition · all medicines · read 12 November 2026
Is there a generic of Posaconazole, and who makes it?
Posaconazole appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 20 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 5.7 and 13.7 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.
- Posaconazole appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 20 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 5.7 and 13.7 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, Delayed Release, Oral
Four or more generic makers listed
Every brand product here is listed as discontinued. 13 generic makers with 13 generic products listed as marketed; the first generic approval is dated 21 August 2019.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Sinotherapeutics Inc | 21 August 2019 | 1 |
| Aet Pharma Us Inc | 1 February 2021 | 1 |
| Biocon Pharma Ltd | 4 February 2022 | 1 |
| Dr Reddys Laboratories Ltd | 7 April 2022 | 1 |
| Specgx Llc | 10 May 2022 | 1 |
| Hetero Labs Ltd Unit Iii | 8 December 2022 | 1 |
| Amneal Pharmaceuticals Llc | 22 December 2022 | 1 |
| Somerset Therapeutics Llc | 20 June 2023 | 1 |
| Pharmazone | 28 August 2023 | 1 |
| Aurobindo Pharma Ltd | 18 July 2024 | 1 |
| Msn Laboratories Private Ltd | 24 February 2025 | 1 |
| Qilu Pharmaceutical Hainan Co Ltd | 23 April 2025 | 1 |
1 more makers are listed in the data.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Intravenous
Four or more generic makers listed
Every brand product here is listed as discontinued. 6 generic makers with 6 generic products listed as marketed; the first generic approval is dated 25 May 2022.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Ph Health Ltd | 25 May 2022 | 1 |
| Eugia Pharma Specialities Ltd | 26 December 2023 | 1 |
| Fresenius Kabi Usa Llc | 26 December 2023 | 1 |
| Gland Pharma Ltd | 26 December 2023 | 1 |
| Mylan Laboratories Ltd | 26 December 2023 | 1 |
| Aspiro Pharma Ltd | 23 December 2024 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Suspension, Oral
One to three generic makers listed
Brand listed as marketed: Noxafil. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 15 May 2020.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hikma Pharmaceuticals Usa Inc | 15 May 2020 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
For Suspension, Delayed Release, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Noxafil Powdermix Kit. No generic is listed as marketed.
Patents and exclusivities still listed
- 27 January 2029Exclusivity I-984 Noxafil Powdermix Kit
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.