FDA Orange Book
Is there a generic for Olpruva?
Olpruva contains sodium phenylbutyrate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Olpruva (sodium phenylbutyrate). The Orange Book shows its last listed patent expires October 17, 2036.
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Olpruva products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 0.5GM/PACKET | Marketed (Rx) | None | 0 | None |
| for suspension, oral | 1GM/PACKET | Marketed (Rx) | None | 0 | None |
| for suspension, oral | 2GM/PACKET | Marketed (Rx) | None | 0 | None |
| for suspension, oral | 3GM/PACKET | Marketed (Rx) | None | 0 | None |
| for suspension, oral | 4GM/PACKET | Marketed (Rx) | None | 0 | None |
| for suspension, oral | 5GM/PACKET | Marketed (Rx) | None | 0 | None |
| for suspension, oral | 6.67GM/PACKET | Marketed (Rx) | None | 0 | None |
| for suspension, oral | 6GM/PACKET | Marketed (Rx) | None | 0 | None |
NDA 214860, held by ACER THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Olpruva patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11202767 | October 17, 2036 | Method of use | U-3502 | 214860 |
| 11433041 | October 17, 2036 | Drug product | None | 214860 |
| 11154521 | October 17, 2036 | Drug product | None | 214860 |
Questions
Is there a generic for Olpruva?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Olpruva (sodium phenylbutyrate). The Orange Book shows its last listed patent expires October 17, 2036.
What is the generic name for Olpruva?
The active ingredient in Olpruva is sodium phenylbutyrate, per the FDA Orange Book.
When does the Olpruva patent expire?
The last patent listed for Olpruva in the Orange Book expires October 17, 2036. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.