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OmniRx › Tools › Generic competition check › Midazolam

Generic competition · all medicines · read 12 November 2026

Is there a generic of Midazolam, and who makes it?

Midazolam appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 3 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 2.1 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.
Midazolam2 dosage-form groups in the Orange Book
3generic makers listed
  1. Midazolam appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 3 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 2.1 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.

Solution, Intravenous

One to three generic makers listed

Brand listed as marketed: Midazolam In 0.9% Sodium Chloride. 3 generic makers with 6 generic products listed as marketed; the first generic approval is dated 17 April 2023.

2020202520302035204003brand 2021Hikma Pharmaceuticals Usa Inc, first approval 17 April 2023Gland Pharma Ltd, first approval 12 August 2024B Braun Medical Inc, first approval 1 May 2025data datePatent 10966990 listed to expire 20 June 2038
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Hikma Pharmaceuticals Usa Inc17 April 20232
Gland Pharma Ltd12 August 20242
B Braun Medical Inc1 May 20252

Patents and exclusivities still listed

  • 20 June 2038Patent 10966990 drug product

Spray, Nasal

Brand listed, no generic listed as marketed

Brand listed as marketed: Nayzilam. No generic is listed as marketed.

201520202025203001brand 2019data datePatent 9687495 listed to expire 18 January 2028Patent 9289432 listed to expire 18 January 2028Patent 8217033 listed to expire 18 January 2028Patent 8809322 listed to expire 18 January 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 18 January 2028Patent 9687495 drug product
  • 18 January 2028Patent 9289432 drug product
  • 18 January 2028Patent 8217033 drug product
  • 18 January 2028Patent 8809322 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.