SODIUM PHENYLBUTYRATE; TAURURSODIOL - Generic Drug Details

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

Sodium phenylbutyrate; taurursodiol is the generic ingredient in one branded drug marketed by Amylyx and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium phenylbutyrate; taurursodiol has fifty-four patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for SODIUM PHENYLBUTYRATE; TAURURSODIOL

International Patents:	54
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	SODIUM PHENYLBUTYRATE; TAURURSODIOL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SODIUM PHENYLBUTYRATE; TAURURSODIOL

Constraining patent/regulatory exclusivity:

TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS

Dosage:

FOR SUSPENSION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for SODIUM PHENYLBUTYRATE; TAURURSODIOL

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

US Patents and Regulatory Information for SODIUM PHENYLBUTYRATE; TAURURSODIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes			Y
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes			Y

International Patents for SODIUM PHENYLBUTYRATE; TAURURSODIOL

Country	Patent Number	Title	Estimated Expiration
Japan	2021008473	細胞生存率を向上させるための組成物およびその使用方法 (COMPOSITION FOR IMPROVING CELL VIABILITY AND METHOD OF USE THEREOF)
Japan	6766198
South Korea	20220066178	세포 생존력을 향상시키기 위한 조성물 및 이의 사용 방법 (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF)
Japan	2023507152	胆汁酸及びフェニル酪酸化合物の組成物
China	109999043	用于提高细胞存活力的组合物和使用该组合物的方法 (Compositions for improving cell viability and methods of use thereof)
Argentina	120774	COMPOSICIONES DE ÁCIDOS BILIARES Y COMPUESTOS DE FENILBUTIRATO

Supplementary Protection Certificates for SODIUM PHENYLBUTYRATE; TAURURSODIOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1948158	16C0018	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
0957929	SPC/GB06/021	United Kingdom		PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
1856135	2020/017	Ireland		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTRATION NO/DATE: EU/1/19/1405 20200113
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
3141251	SPC/GB20/075	United Kingdom		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 3350, SODIUM SULPH; REGISTERED: IS IS/1/17/063/01 20171016; UK PL 20011/0040 20171016
1912999	1490062-5	Sweden		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516