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OmniRx › Tools › Generic competition check › Dantrolene Sodium

Generic competition · all medicines · read 12 November 2026

Is there a generic of Dantrolene Sodium, and who makes it?

Dantrolene Sodium appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 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.

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.
Dantrolene Sodium3 dosage-form groups in the Orange Book
4generic makers listed
  1. Dantrolene Sodium appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 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. 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.

Capsule, Oral

One to three generic makers listed

Brand listed as marketed: Dantrium. 2 generic makers with 6 generic products listed as marketed; the first generic approval is dated 1 March 2005.

20052010201520202025203002Impax Laboratories Inc, first approval 1 March 2005Elite Laboratories Inc, first approval 24 October 2005data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Impax Laboratories Inc1 March 20053
Elite Laboratories Inc24 October 20053

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Injectable, Injection

One to three generic makers listed

Brand listed as marketed: Dantrium. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 24 July 2007.

20052010201520202025203002Uswm Llc, first approval 24 July 2007Hikma Pharmaceuticals Llc, first approval 19 June 2017data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Uswm Llc24 July 20071
Hikma Pharmaceuticals Llc19 June 20171

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

For Suspension, Intravenous

Brand listed, no generic listed as marketed

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

2010201520202025203001brand 2014data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

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.