Generic competition · all medicines · read 12 November 2026
Is there a generic of Sodium Phenylbutyrate, and who makes it?
Sodium Phenylbutyrate appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 3 generic makers listed as marketed across them. 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. Where both are dated, the first generic approval came between 15.5 and 16.9 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.
- Sodium Phenylbutyrate appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 3 generic makers listed as marketed across them.
- 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.
- Where both are dated, the first generic approval came between 15.5 and 16.9 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.
For Suspension, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Olpruva. No generic is listed as marketed.
Patents and exclusivities still listed
- 17 October 2036Patent 11202767
- 17 October 2036Patent 11433041 drug product
- 17 October 2036Patent 11154521 drug product
Tablet, Oral
One to three generic makers listed
Every brand product here is listed as discontinued. 3 generic makers with 3 generic products listed as marketed; the first generic approval is dated 18 November 2011.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Ph Health Ltd | 15 April 2016 | 1 |
| Glenmark Pharmaceuticals Ltd | 1 November 2022 | 1 |
| Navinta Llc | 17 February 2026 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Powder, Oral
One to three generic makers listed
Every brand product here is listed as discontinued. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 22 March 2013.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Ph Health Ltd | 15 June 2016 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Pellets, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Pheburane. 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.
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.