Generic competition · all medicines · read 12 November 2026
Is there a generic of Pyridostigmine Bromide, and who makes it?
Pyridostigmine Bromide appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 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. 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.
- Pyridostigmine Bromide appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 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.
- 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, Oral
Four or more generic makers listed
Brand listed as marketed: Mestinon. 4 generic makers with 6 generic products listed as marketed; the first generic approval is dated 27 November 1990.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Impax Laboratories Inc | 24 April 2003 | 2 |
| Ani Pharmaceuticals Inc | 8 October 2003 | 1 |
| Zydus Pharmaceuticals Usa Inc | 22 June 2015 | 1 |
| Mlv Pharma Llc | 20 July 2018 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Syrup, Oral
Four or more generic makers listed
Brand listed as marketed: Mestinon. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 8 March 2019.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Novitium Pharma Llc | 8 March 2019 | 1 |
| Rising Pharma Holding Inc | 9 January 2020 | 1 |
| Amneal Pharmaceuticals Llc | 10 January 2020 | 1 |
| Milla Pharmaceuticals Inc | 19 April 2022 | 1 |
| Msn Laboratories Private Ltd | 21 September 2023 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Extended Release, Oral
One to three generic makers listed
Brand listed as marketed: Mestinon. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 26 June 2015.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Alvogen Inc | 26 June 2015 | 1 |
| Rising Pharma Holdings Inc | 15 August 2017 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Injectable, Injection
Brand listed, no generic listed as marketed
Brand listed as marketed: Mestinon and Regonol. 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.