Generic competition · all medicines · read 12 November 2026

Is there a generic of Berotralstat Dihydrochloride, and who makes it?

Berotralstat Dihydrochloride 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.

Berotralstat Dihydrochloride2 dosage-form groups in the Orange Book

0generic makers listed

Berotralstat Dihydrochloride 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.
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.

Pellets, Oral

Brand listed, no generic listed as marketed

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

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

Patents and exclusivities still listed

11 December 2028Exclusivity NP Orladeyo
11 June 2029Exclusivity PED Orladeyo
9 March 2035Patent 11708333
9 March 2035Patent 11230530
9 March 2035Patent 10689346
9 March 2035Patent 12116346 drug substance
9 March 2035Patent 10329260 drug substance
7 April 2035Patent 10125102 drug substance
9 September 2035Patent 11708333*PED
9 September 2035Patent 10329260*PED

24 more patents are listed.

Capsule, Oral

Brand listed, no generic listed as marketed

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

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

Patents and exclusivities still listed

3 December 2027Exclusivity ODE-333 Orladeyo
3 June 2028Exclusivity PED Orladeyo
9 March 2035Patent 11230530
9 March 2035Patent 11708333
9 March 2035Patent 10689346
9 March 2035Patent 10329260 drug substance
9 March 2035Patent 12116346 drug substance
7 April 2035Patent 10125102 drug substance
9 September 2035Patent 12116346*PED
9 September 2035Patent 11708333*PED

24 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.