Orange Book product · Brand (NDA)

OLPRUVA

SODIUM PHENYLBUTYRATE

Brand (NDA)NDA 214860RX ACER

Dec 22, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 22, 2022
3 yr 7 mo ago
Today
Patent 11154521 expires
Listed drug product patent expiration.
Oct 17, 2036
in 10 yr 6 mo
Patent 11202767 expires
Listed method-of-use patent (U-3502) expiration.
Oct 17, 2036
in 10 yr 6 mo
Patent 11433041 expires
Listed drug product patent expiration.
Oct 17, 2036
in 10 yr 6 mo

Active ingredient

SODIUM PHENYLBUTYRATE

Strength

5GM/PACKET

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 214860

Product number

004

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11154521	Oct 17, 2036	in 10 yr 6 mo	Product
11202767	Oct 17, 2036	in 10 yr 6 mo	U-3502
11433041	Oct 17, 2036	in 10 yr 6 mo	Product