Generic competition · all medicines · read 12 November 2026
Is there a generic of Tobramycin, and who makes it?
Tobramycin appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 15 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. Where both are dated, the first generic approval came 15.8 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.
- Tobramycin appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 15 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.
- Where both are dated, the first generic approval came 15.8 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.
Solution, Inhalation
Four or more generic makers listed
Brand listed as marketed: Bethkis, Kitabis Pak and Tobi. 9 generic makers with 10 generic products listed as marketed; the first generic approval is dated 10 October 2013.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Teva Pharmaceuticals Usa | 10 October 2013 | 1 |
| Hikma Pharmaceuticals Usa Inc | 28 May 2014 | 1 |
| Amneal Pharmaceuticals Of New York Llc | 13 July 2015 | 1 |
| Lupin Inc | 22 March 2017 | 1 |
| Dr Reddys Laboratories Sa | 9 July 2018 | 1 |
| Sun Pharmaceutical Industries Ltd | 26 December 2019 | 1 |
| Alkem Laboratories Ltd | 1 April 2021 | 1 |
| Mankind Pharma Ltd | 22 September 2022 | 2 |
| Micro Labs Ltd | 27 July 2023 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution/Drops, Ophthalmic
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 13 December 1984.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Sandoz Inc | 13 December 1984 | 1 |
| Bausch And Lomb Inc | 29 November 1993 | 1 |
| Chartwell Rx Sciences Llc | 11 September 2001 | 1 |
| Somerset Therapeutics Llc | 28 June 2017 | 1 |
| Alembic Pharmaceuticals Ltd | 19 April 2019 | 1 |
| Gland Pharma Ltd | 9 March 2021 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Ointment, Ophthalmic
Brand listed, no generic listed as marketed
Brand listed as marketed: Tobrex. 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.
Powder, Inhalation
Brand listed, no generic listed as marketed
Brand listed as marketed: Tobi Podhaler. No generic is listed as marketed.
Patents and exclusivities still listed
- 12 September 2028Patent 8869794 drug product
- 4 November 2030Patent 10207066 drug product
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.