Generic competition · all medicines · read 12 November 2026

Is there a generic of Fidaxomicin, and who makes it?

Fidaxomicin appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 5 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. Where both are dated, the first generic approval came 12.6 years after the first brand approval. 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.

Fidaxomicin2 dosage-form groups in the Orange Book

5generic makers listed

Fidaxomicin appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 5 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.
Where both are dated, the first generic approval came 12.6 years after the first brand approval.
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.

Tablet, Oral

Four or more generic makers listed

Brand listed as marketed: Dificid. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 16 January 2024.

generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Generic maker (applicant)	First approval	Products
Actavis Laboratories Fl Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc	16 January 2024	1
Torrent Pharmaceuticals Ltd	27 January 2026	1
Apotex Inc	2 February 2026	1
Sandoz Inc	13 August 2026	1
Hikma Pharmaceuticals Usa Inc	7 October 2026	1

Patents and exclusivities still listed

24 January 2027Exclusivity ODE-367 Dificid
4 March 2027Patent 7906489
31 July 2027Patent 8859510
31 July 2027Patent 7378508 drug substance
31 July 2027Patent 7863249 drug substance
4 September 2027Patent 7906489*PED
31 January 2028Patent 7378508*PED
31 January 2028Patent 7863249*PED
31 January 2028Patent 8859510*PED

For Suspension, Oral

Brand listed, no generic listed as marketed

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

generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

24 January 2027Exclusivity ODE-367 Dificid
4 March 2027Patent 7906489
31 July 2027Patent 8859510
31 July 2027Patent 7378508 drug substance
31 July 2027Patent 7863249 drug product
4 September 2027Patent 7906489*PED
31 January 2028Patent 7378508*PED
31 January 2028Patent 7863249*PED
31 January 2028Patent 8859510*PED

2 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.