Generic competition · all medicines · read 12 November 2026
Is there a generic of Thiotepa, and who makes it?
Thiotepa appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 8 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 3.1 and 6.3 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.
- Thiotepa appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 8 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 3.1 and 6.3 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.
Injectable, Injection
Four or more generic makers listed
Every brand product here is listed as discontinued. 4 generic makers with 4 generic products listed as marketed; the first generic approval is dated 2 April 2001.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| West-Ward Pharmaceuticals International Ltd | 2 April 2001 | 1 |
| Dr Reddys Laboratories Ltd | 4 May 2018 | 1 |
| Penn Life Sciences Llc | 10 January 2020 | 1 |
| Regcon Holdings Llc | 8 December 2021 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Powder, Intracavitary, Intravenous, Intravesical
Four or more generic makers listed
Brand listed as marketed: Tepadina. 5 generic makers with 8 generic products listed as marketed; the first generic approval is dated 4 March 2020.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Msn Laboratories Private Ltd | 4 March 2020 | 2 |
| Gland Pharma Ltd | 8 March 2021 | 2 |
| Hikma Pharmaceuticals Usa Inc | 5 September 2023 | 1 |
| Meitheal Pharmaceuticals Inc | 26 December 2023 | 2 |
| Regcon Holdings Llc | 20 August 2024 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Powder, Intravenous
Brand listed, no generic listed as marketed
Brand listed as marketed: Tepadina And Sodium Chloride. No generic is listed as marketed.
Patents and exclusivities still listed
- 31 May 2037Patent 9931458 drug product
Solution, Intravenous
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.