FDA Orange Book · active-ingredient family
Sodium phenylbutyrate
Sodium phenylbutyrate is approved as 4 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OLPRUVA · NDA 214860
4
Brand (NDA)
6
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · for suspension, pellets, powder, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OLPRUVARLD×8 | ACER | NDA 214860 | — | Oct 10, 2025 | |
| PHEBURANERLD | MEDUNIK | NDA 216513 | — | Jun 17, 2022 | |
| BUPHENYLRLD | HORIZON THERAP US | NDA 020572 | — | May 13, 1996 | |
| BUPHENYLRLD | HORIZON THERAP US | NDA 020573 | — | Apr 30, 1996 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM PHENYLBUTYRATE | NAVINTA LLC | ANDA 220418 | AB | Feb 17, 2026 | |
| SODIUM PHENYLBUTYRATE | GLENMARK PHARMS LTD | ANDA 216462 | AB | Nov 01, 2022 | |
| SODIUM PHENYLBUTYRATE | PH HEALTH | ANDA 203918 | AB | Jun 15, 2016 | |
| SODIUM PHENYLBUTYRATE | PH HEALTH | ANDA 204395 | AB | Apr 15, 2016 | |
| SODIUM PHENYLBUTYRATE | SIGMAPHARM LABS LLC | ANDA 202819 | AB | Mar 22, 2013 | |
| SODIUM PHENYLBUTYRATE | ALVOGEN | ANDA 090910 | — | Nov 18, 2011 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11202767 | Oct 17, 2036 | in 10 yr 6 mo | U-3502 |
| 11433041 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 11154521 | Oct 17, 2036 | in 10 yr 6 mo | Product |
Sodium phenylbutyrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
