You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

Details for New Drug Application (NDA): 214860


✉ Email this page to a colleague

« Back to Dashboard


NDA 214860 describes OLPRUVA, which is a drug marketed by Acer and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the OLPRUVA profile page.

The generic ingredient in OLPRUVA is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
Summary for 214860
Tradename:OLPRUVA
Applicant:Acer
Ingredient:sodium phenylbutyrate
Patents:3
Suppliers and Packaging for NDA: 214860
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLPRUVA sodium phenylbutyrate FOR SUSPENSION;ORAL 214860 NDA Acer Therapeutics Inc. 72542-200 72542-200-09 90 BOX in 1 CARTON (72542-200-09) / 1 KIT in 1 BOX (72542-200-02) * 1 FOR SUSPENSION in 1 PACKET (72542-002-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01)
OLPRUVA sodium phenylbutyrate FOR SUSPENSION;ORAL 214860 NDA Acer Therapeutics Inc. 72542-300 72542-300-09 90 BOX in 1 CARTON (72542-300-09) / 1 KIT in 1 BOX (72542-300-02) * 1 FOR SUSPENSION in 1 PACKET (72542-003-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength2GM/PACKET
Approval Date:Dec 22, 2022TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Oct 17, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Oct 17, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF A UREA CYCLE DISORDER INVOLVING DEFICIENCIES OF CARBAMYLPHOSPHATE SYNTHETASE, ORNITHINE TRANSCARBAMYLASE, OR ARGININOSUCCINIC ACID SYNTHETASE
Patent:⤷  Sign UpPatent Expiration:Oct 17, 2036Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.