SODIUM PHENYLBUTYRATE - Generic Drug Details

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, Par Pharm, 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:	38
Patent Applications:	2,756
Formulation / Manufacturing:	see details
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
Maastricht University	Phase 4
Liminal BioSciences Ltd.	Phase 1
University of Nottingham	N/A

See all SODIUM PHENYLBUTYRATE clinical trials

Pharmacology for SODIUM PHENYLBUTYRATE

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

US Patents and Regulatory Information for SODIUM PHENYLBUTYRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-001	Dec 22, 2022		RX	Yes	No			Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-002	Dec 22, 2022		RX	Yes	No
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-004	Dec 22, 2022		RX	Yes	No			Y
Glenmark Pharms Ltd	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	TABLET;ORAL	216462-001	Nov 1, 2022	AB	RX	No	No
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-001	Dec 22, 2022		RX	Yes	No
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-003	Dec 22, 2022		RX	Yes	No			Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-006	Dec 22, 2022		RX	Yes	Yes			Y

Expired US Patents for SODIUM PHENYLBUTYRATE

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
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	TABLET;ORAL	020572-001	May 13, 1996

EU/EMA Drug Approvals for SODIUM PHENYLBUTYRATE

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

International Patents for SODIUM PHENYLBUTYRATE

Country	Patent Number	Title	Estimated Expiration
Brazil	112018068665	composições palatáveis incluindo o fenilbutirato de sódio e usos das mesmas
Spain	2922749
Poland	3429559
Australia	2016398029	Palatable compositions including sodium phenylbutyrate and uses thereof
Israel	296490	הרכבים טעימים הכוללים נתרן פנילביוטירייט ושימושים עבורם (Palatable compositions including sodium phenylbutyrate and uses thereof)
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
Serbia	63383	SASTAVI PRIJATNOG UKUSA KOJI UKLJUČUJU NATRIJUM FENILBUTIRAT I NJIHOVA PRIMENA (PALATABLE COMPOSITIONS INCLUDING SODIUM PHENYLBUTYRATE AND USES THEREOF)

Supplementary Protection Certificates for SODIUM PHENYLBUTYRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1856135	LUC00153	Luxembourg		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
2563920	CR 2019 00001	Denmark		PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
1912999	1490062-5	Sweden		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
2203431	CR 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119