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OmniRx › Tools › Generic competition check › Lefamulin Acetate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Lefamulin Acetate, and who makes it?

Lefamulin Acetate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 2 groups have 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.
Lefamulin Acetate2 dosage-form groups in the Orange Book
0generic makers listed
  1. Lefamulin Acetate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  2. 2 groups have 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.

Solution, Intravenous

Brand listed, no generic listed as marketed

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

20152020202520302035204001brand 2019data datePatent 8153689 listed to expire 19 March 2028Patent 8071643 listed to expire 25 March 2033Patent 12121582 listed to expire 14 June 2036Exclusivity GAIN to 19 August 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 19 August 2029Exclusivity GAIN Xenleta
  • 19 March 2028Patent 8153689 drug substance
  • 25 March 2033Patent 8071643 drug substance
  • 14 June 2036Patent 12121582 drug product

Tablet, Oral

Brand listed, no generic listed as marketed

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

2015202020252030203501brand 2019data datePatent 8153689 listed to expire 19 March 2028Patent 9120727 listed to expire 23 May 2031Patent 8071643 listed to expire 25 March 2033Exclusivity GAIN to 19 August 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 19 August 2029Exclusivity GAIN Xenleta
  • 19 March 2028Patent 8153689 drug substance
  • 23 May 2031Patent 9120727 drug substance
  • 25 March 2033Patent 8071643 drug substance

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.