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OmniRx › Tools › Generic competition check › Birch Triterpenes

Generic competition · all medicines · read 12 November 2026

Is there a generic of Birch Triterpenes, and who makes it?

Birch Triterpenes 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.
Birch Triterpenes1 dosage-form group in the Orange Book
0generic makers listed
  1. Birch Triterpenes 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, Topical

Brand listed, no generic listed as marketed

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

2020202520302035204001brand 2023data datePatent 8828444 listed to expire 21 June 2027Patent 9827214 listed to expire 24 November 2030Patent 9352041 listed to expire 24 November 2030Patent 11266660 listed to expire 4 January 2039Patent 12268695 listed to expire 4 January 2039Patent 11083733 listed to expire 4 January 2039Exclusivity NCE to 18 December 2028Exclusivity ODE-460 to 18 December 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 18 December 2028Exclusivity NCE Filsuvez
  • 18 December 2030Exclusivity ODE-460 Filsuvez
  • 21 June 2027Patent 8828444 drug product
  • 24 November 2030Patent 9827214
  • 24 November 2030Patent 9352041
  • 4 January 2039Patent 11266660
  • 4 January 2039Patent 12268695
  • 4 January 2039Patent 11083733 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.