Generic competition · all medicines · read 12 November 2026
Is there a generic of Esmolol Hydrochloride, and who makes it?
Esmolol Hydrochloride appears in 2 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 16 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.
- Esmolol Hydrochloride appears in 2 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 16 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: Brevibloc, Brevibloc Double Strength In Plastic Container and Brevibloc In Plastic Container. 8 generic makers with 14 generic products listed as marketed; the first generic approval is dated 10 August 2004.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hikma Pharmaceuticals Usa Inc | 10 August 2004 | 1 |
| Mylan Institutional Llc | 2 May 2005 | 1 |
| Eugia Pharma Specialities Ltd | 23 July 2015 | 3 |
| Mylan Laboratories Ltd | 8 June 2018 | 2 |
| Sagent Pharmaceuticals Inc | 8 June 2018 | 2 |
| Gland Pharma Ltd | 14 August 2019 | 1 |
| Hq Specialty Pharma Corp | 2 December 2022 | 2 |
| Amneal Eu Ltd | 13 December 2022 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Intravenous
Brand listed, no generic listed as marketed
Brand listed as marketed: Esmolol Hydrochloride Double Strength In Plastic Container and Esmolol Hydrochloride In Plastic Container. No generic is listed as marketed.
Patents and exclusivities still listed
- 15 March 2033Patent 8835505 drug product
- 15 March 2033Patent 8829054 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.