Generic competition · all medicines · read 12 November 2026
Is there a generic of Cysteamine Bitartrate, and who makes it?
Cysteamine Bitartrate appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 3 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.
- Cysteamine Bitartrate appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
- 3 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.
Capsule, Delayed Release, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Procysbi. No generic is listed as marketed.
Patents and exclusivities still listed
- 26 January 2027Patent 9198882
- 26 January 2027Patent 9192590
- 26 January 2027Patent 9925158 drug substance
- 26 January 2027Patent 9925157 drug substance
- 26 January 2027Patent 9925156 drug substance
- 26 July 2027Patent 9198882*PED
- 26 July 2027Patent 9192590*PED
- 26 July 2027Patent 9925156*PED
16 more patents are listed.
Capsule, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Cystagon. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Granule, Delayed Release, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Procysbi. No generic is listed as marketed.
Patents and exclusivities still listed
- 26 January 2027Patent 9198882
- 26 January 2027Patent 9192590
- 26 January 2027Patent 9925156 drug product
- 26 January 2027Patent 9925157 drug product
- 26 January 2027Patent 9925158 drug product
- 26 July 2027Patent 9198882*PED
- 26 July 2027Patent 9192590*PED
- 26 July 2027Patent 9925156*PED
16 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.