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Last Updated: May 4, 2024

SODIUM PHENYLBUTYRATE; TAURURSODIOL - Generic Drug Details

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

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

Generic Entry Date for SODIUM PHENYLBUTYRATE; TAURURSODIOL^: ⤷ Try a Trial* 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

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

International Patents for SODIUM PHENYLBUTYRATE; TAURURSODIOL

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Country	Patent Number	Title	Estimated Expiration
Brazil	112022011948	COMPOSIÇÕES DE ÁCIDOS BILIARES E COMPOSTOS DE FENILBUTIRATO	⤷ Try a Trial
South Korea	102223250		⤷ Try a Trial
Australia	2019200658	Compositions for improving cell viability and methods of use thereof	⤷ Try a Trial
Japan	2023507152	胆汁酸及びフェニル酪酸化合物の組成物	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SODIUM PHENYLBUTYRATE; TAURURSODIOL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	17C1031	France	⤷ Try a Trial	PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
0186405	SPC/GB00/021	United Kingdom	⤷ Try a Trial	PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
1713823	1490064-1	Sweden	⤷ Try a Trial	PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
2203431	CR 2015 00014	Denmark	⤷ Try a 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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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.

Summary for SODIUM PHENYLBUTYRATE; TAURURSODIOL

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

Pharmacology for SODIUM PHENYLBUTYRATE; TAURURSODIOL

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

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