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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.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Esmolol Hydrochloride2 dosage-form groups in the Orange Book
8generic makers listed
  1. 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.
  2. 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.
  3. Where both are dated, the first generic approval came 16 years after the first brand approval.
  4. 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.

198519901995200020052010201520202025203008brand 1988Hikma Pharmaceuticals Usa Inc, first approval 10 August 2004Mylan Institutional Llc, first approval 2 May 2005Eugia Pharma Specialities Ltd, first approval 23 July 2015Mylan Laboratories Ltd, first approval 8 June 2018Sagent Pharmaceuticals Inc, first approval 8 June 2018Gland Pharma Ltd, first approval 14 August 2019Hq Specialty Pharma Corp, first approval 2 December 2022Amneal Eu Ltd, first approval 13 December 2022data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Hikma Pharmaceuticals Usa Inc10 August 20041
Mylan Institutional Llc2 May 20051
Eugia Pharma Specialities Ltd23 July 20153
Mylan Laboratories Ltd8 June 20182
Sagent Pharmaceuticals Inc8 June 20182
Gland Pharma Ltd14 August 20191
Hq Specialty Pharma Corp2 December 20222
Amneal Eu Ltd13 December 20222

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.

2015202020252030203501brand 2016data datePatent 8835505 listed to expire 15 March 2033Patent 8829054 listed to expire 15 March 2033
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

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.