Generic competition · all medicines · read 12 November 2026
Is there a generic of Mannitol, and who makes it?
Mannitol appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 1 generic maker 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. 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.
- Mannitol appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 1 generic maker 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.
- 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
One to three generic makers listed
Brand listed as marketed: Mannitol 10% In Plastic Container, Mannitol 15% In Plastic Container, Mannitol 20% In Plastic Container and Mannitol 25%. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 21 January 1982.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fresenius Kabi Usa Llc | not dated | 1 |
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: Aridol Kit and Bronchitol. No generic is listed as marketed.
Patents and exclusivities still listed
- 30 October 2027Exclusivity ODE-327 Bronchitol
Solution, Irrigation
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.