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OmniRx › Tools › Generic competition check › Iptacopan Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Iptacopan Hydrochloride, and who makes it?

Iptacopan Hydrochloride 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.
Iptacopan Hydrochloride1 dosage-form group in the Orange Book
0generic makers listed
  1. Iptacopan Hydrochloride 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.

Capsule, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2023data datePatent 10093663 listed to expire 14 July 2034Patent 9682968 listed to expire 14 July 2034Patent 12285422 listed to expire 30 August 2038Patent 11723901 listed to expire 30 August 2038Patent 12384758 listed to expire 17 May 2041Patent 11603363 listed to expire 25 May 2041Patent 12453726 listed to expire 15 July 2041Patent 11951101 listed to expire 15 July 2041Exclusivity I-949 to 7 August 2027Exclusivity I-963 to 20 March 2028Exclusivity NCE to 5 December 2028Exclusivity ODE-456 to 5 December 2030Exclusivity ODE-524 to 20 March 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 7 August 2027Exclusivity I-949 Fabhalta
  • 20 March 2028Exclusivity I-963 Fabhalta
  • 5 December 2028Exclusivity NCE Fabhalta
  • 5 December 2030Exclusivity ODE-456 Fabhalta
  • 20 March 2032Exclusivity ODE-524 Fabhalta
  • 14 July 2034Patent 10093663
  • 14 July 2034Patent 9682968 drug substance
  • 30 August 2038Patent 12285422
  • 30 August 2038Patent 11723901
  • 17 May 2041Patent 12384758
  • 25 May 2041Patent 11603363 drug substance
  • 15 July 2041Patent 12453726
  • 15 July 2041Patent 11951101

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.