Generic competition · all medicines · read 12 November 2026
Is there a generic of Topotecan Hydrochloride, and who makes it?
Topotecan Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 7 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 6.4 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.
- Topotecan Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 7 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 6.4 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.
Injectable, Injection
Four or more generic makers listed
Brand listed as marketed: Hycamtin. 7 generic makers with 7 generic products listed as marketed; the first generic approval is dated 29 November 2010.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fresenius Kabi Usa Llc | 29 November 2010 | 1 |
| Teyro Labs Private Ltd | 1 December 2010 | 1 |
| Actavis Totowa Llc | 2 December 2010 | 1 |
| Sagent Pharmaceuticals Inc | 26 January 2011 | 1 |
| Dr Reddys Laboratories Ltd | 9 March 2011 | 1 |
| Accord Healthcare Inc | 26 June 2013 | 1 |
| Ingenus Pharmaceuticals Llc | 30 November 2016 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Intravenous
One to three generic makers listed
Brand listed as marketed: Topotecan Hydrochloride. 1 generic maker with 2 generic products listed as marketed; the first generic approval is dated 6 July 2017.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Accord Healthcare Inc | 6 July 2017 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Capsule, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Hycamtin. 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.