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OmniRx › Tools › Generic competition check › Omadacycline Tosylate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Omadacycline Tosylate, and who makes it?

Omadacycline Tosylate 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.
Omadacycline Tosylate2 dosage-form groups in the Orange Book
0generic makers listed
  1. Omadacycline Tosylate 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.

Powder, Intravenous

Brand listed, no generic listed as marketed

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

20152020202520302035204001brand 2018data datePatent 10124014 listed to expire 5 March 2029Patent 9724358 listed to expire 5 March 2029Patent 9265740 listed to expire 5 March 2029Patent 10383884 listed to expire 31 October 2037Patent 10835542 listed to expire 31 October 2037Exclusivity GAIN to 2 October 2028Exclusivity M-320 to 13 May 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 2 October 2028Exclusivity GAIN Nuzyra
  • 13 May 2029Exclusivity M-320 Nuzyra
  • 5 March 2029Patent 10124014
  • 5 March 2029Patent 9724358
  • 5 March 2029Patent 9265740 drug product
  • 31 October 2037Patent 10383884
  • 31 October 2037Patent 10835542

Tablet, Oral

Brand listed, no generic listed as marketed

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

20152020202520302035204001brand 2018data datePatent 9724358 listed to expire 5 March 2029Patent 10124014 listed to expire 5 March 2029Patent 8383610 listed to expire 23 September 2030Patent 9265740 listed to expire 24 October 2030Patent 9314475 listed to expire 18 March 2031Patent 10111890 listed to expire 3 August 2037Patent 10383884 listed to expire 31 October 2037Patent 10835542 listed to expire 31 October 2037Exclusivity GAIN to 2 October 2028Exclusivity M-320 to 13 May 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 2 October 2028Exclusivity GAIN Nuzyra
  • 13 May 2029Exclusivity M-320 Nuzyra
  • 5 March 2029Patent 9724358
  • 5 March 2029Patent 10124014
  • 23 September 2030Patent 8383610 drug substance
  • 24 October 2030Patent 9265740 drug product
  • 18 March 2031Patent 9314475 drug product
  • 3 August 2037Patent 10111890
  • 31 October 2037Patent 10383884
  • 31 October 2037Patent 10835542

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.