Sodium phenylbutyrate - Generic Drug Details

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What are the generic drug sources for sodium phenylbutyrate and what is the scope of freedom to operate?

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

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

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

Summary for sodium phenylbutyrate

International Patents:	25
US Patents:	8
Tradenames:	5
Applicants:	8
NDAs:	10
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	39
Patent Applications:	2,759
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
Jerry Vockley, MD, PhD	Phase 2
Acer Therapeutics Inc.	Phase 2
Maastricht University	Phase 4

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
Medunik	PHEBURANE	sodium phenylbutyrate	PELLETS;ORAL	216513-001	Jun 17, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-003	Dec 22, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	TABLET;ORAL	020572-001	May 13, 1996	⤷ Sign Up	⤷ Sign Up
>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/002500 Treatment of chronic management of urea-cycle disorders.	Authorised	no	no	no	2013-07-30
Immedica Pharma AB	Ammonaps	sodium phenylbutyrate	EMEA/H/C/000219 Ammonaps 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
Japan	2022106927	フェニル酪酸ナトリウムを含む口当たりの良い組成物及びその使用	⤷ Sign Up
Saudi Arabia	518400020	تركيبات مستساغة تتضمن فينيل بيوتيرات الصوديوم واستخداماتها (Palatable Compositions Including Sodium Phenylbutyrate and Uses Thereof)	⤷ Sign Up
European Patent Office	3429559	COMPOSITIONS AU GOÛT AGRÉABLE COMPRENANT DU PHÉNYLBUTYRATE DE SODIUM ET LEURS UTILISATIONS (PALATABLE COMPOSITIONS INCLUDING SODIUM PHENYLBUTYRATE AND USES THEREOF)	⤷ Sign Up
Singapore	11201807979S	PALATABLE COMPOSITIONS INCLUDING SODIUM PHENYLBUTYRATE AND USES THEREOF	⤷ Sign Up
Canada	3017573	COMPOSITIONS AU GOUT AGREABLE COMPRENANT DU PHENYLBUTYRATE DE SODIUM ET LEURS UTILISATIONS (PALATABLE COMPOSITIONS INCLUDING SODIUM PHENYLBUTYRATE AND USES THEREOF)	⤷ Sign Up
>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
0480717	98C0022	France	⤷ Sign Up	PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
2666774	CA 2020 00037	Denmark	⤷ Sign Up	PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
2932970	18C1043	France	⤷ Sign Up	PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
1856135	LUC00153	Luxembourg	⤷ Sign Up	PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
1874117	SPC/GB14/041	United Kingdom	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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