Last Updated: August 1, 2026

Sodium phenylbutyrate - Generic Drug Details

Name: sodium phenylbutyrate Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic sources for sodium phenylbutyrate and what is the scope of patent protection?

Sodium phenylbutyrate is the generic ingredient in five branded drugs marketed by Acer, Medunik, Horizon Therap Us, Ph Health, Sigmapharm Labs Llc, Alvogen, Glenmark Pharms Ltd, Navinta Llc, and Amylyx, and is included in eleven NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium phenylbutyrate has thirty-five patent family members in twenty-two countries.

There are four drug master file entries for sodium phenylbutyrate. Seven suppliers are listed for this compound.

Summary for sodium phenylbutyrate

International Patents:	35
US Patents:	8
Tradenames:	5
Applicants:	9
NDAs:	11
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	43
Patent Applications:	3,590
What excipients (inactive ingredients) are in sodium phenylbutyrate?	sodium phenylbutyrate excipients list
DailyMed Link:	sodium phenylbutyrate at DailyMed

Recent Clinical Trials for sodium phenylbutyrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Pennsylvania	EARLY_PHASE1
National Heart, Lung, and Blood Institute (NHLBI)	EARLY_PHASE1
Zevra Therapeutics	PHASE1

See all sodium phenylbutyrate clinical trials

Pharmacology for sodium phenylbutyrate

Drug Class	Nitrogen Binding Agent
Mechanism of Action	Ammonium Ion Binding Activity

Anatomical Therapeutic Chemical (ATC) Classes for sodium phenylbutyrate

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for sodium phenylbutyrate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sigmapharm Labs Llc	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	POWDER;ORAL	202819-001	Mar 22, 2013	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-003	Dec 22, 2022		RX	Yes	No	11,202,767	⤷ Start Trial				⤷ Start Trial
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-006	Dec 22, 2022		RX	Yes	No	11,202,767	⤷ Start Trial				⤷ Start Trial
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-005	Dec 22, 2022		RX	Yes	No	11,154,521	⤷ Start Trial	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for sodium phenylbutyrate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	POWDER;ORAL	020573-001	Apr 30, 1996	4,457,942	⤷ Start Trial
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	TABLET;ORAL	020572-001	May 13, 1996	4,457,942	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for sodium phenylbutyrate

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eurocept International B. V.	Pheburane	sodium phenylbutyrate	EMEA/H/C/002500Treatment of chronic management of urea-cycle disorders.	Authorised	no	no	no	2013-07-30
Immedica Pharma AB	Ammonaps	sodium phenylbutyrate	EMEA/H/C/000219Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase.It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.	Authorised	no	no	no	1999-12-07
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for sodium phenylbutyrate

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Country	Patent Number	Title	Estimated Expiration
Australia	2016398029		⤷ Start Trial
Brazil	112018068665		⤷ Start Trial
Canada	3017573		⤷ Start Trial
Cyprus	1125450		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for sodium phenylbutyrate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1912999	2014/058	Ireland	⤷ Start Trial	PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
2203431	15C0013	France	⤷ Start Trial	PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
3347352	SPC/GB22/064	United Kingdom	⤷ Start Trial	PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REGISTERED: UK EU/1/22/1671(FOR NI) 20220819; UK MORE ON HISTORY TAB 20220819
2203431	1590018-6	Sweden	⤷ Start Trial	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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