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OmniRx › Tools › Generic competition check › Sofpironium Bromide

Generic competition · all medicines · read 12 November 2026

Is there a generic of Sofpironium Bromide, and who makes it?

Sofpironium Bromide appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 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.
Sofpironium Bromide1 dosage-form group in the Orange Book
0generic makers listed
  1. Sofpironium Bromide appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  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.

Gel, Metered, Topical

Brand listed, no generic listed as marketed

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

2020202520302035204001brand 2024data datePatent 8147809 listed to expire 26 March 2027Patent 8628759 listed to expire 13 November 2027Patent 10383846 listed to expire 14 March 2034Patent 9492429 listed to expire 14 March 2034Patent 9895350 listed to expire 14 March 2034Patent 9220707 listed to expire 14 March 2034Patent 12357609 listed to expire 22 May 2034Patent 12156865 listed to expire 22 May 2034Patent 12398102 listed to expire 22 May 2034Patent 11084788 listed to expire 22 May 2034Patent 11052067 listed to expire 22 May 2034Patent 11034652 listed to expire 22 May 2034Patent 11026919 listed to expire 22 May 2034Patent 10961191 listed to expire 22 May 2034Patent 10959983 listed to expire 22 May 2034Patent 10952990 listed to expire 22 May 2034Patent 10947192 listed to expire 22 May 2034Patent 11123325 listed to expire 20 July 2037Patent 12703682 listed to expire 22 May 2040Patent 11584715 listed to expire 22 May 2040Patent 11566000 listed to expire 22 May 2040Exclusivity NCE to 20 June 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 20 June 2029Exclusivity NCE Sofdra
  • 26 March 2027Patent 8147809 drug substance
  • 13 November 2027Patent 8628759
  • 14 March 2034Patent 10383846
  • 14 March 2034Patent 9492429 drug product
  • 14 March 2034Patent 9895350
  • 14 March 2034Patent 9220707
  • 22 May 2034Patent 12357609 drug product
  • 22 May 2034Patent 12156865 drug product

13 more patents are listed.

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.