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Last Updated: November 7, 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*:
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

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amylyx RELYVRIO sodium phenylbutyrate; taurursodiol FOR SUSPENSION;ORAL 216660-001 Sep 29, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amylyx RELYVRIO sodium phenylbutyrate; taurursodiol FOR SUSPENSION;ORAL 216660-001 Sep 29, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amylyx RELYVRIO sodium phenylbutyrate; taurursodiol FOR SUSPENSION;ORAL 216660-001 Sep 29, 2022 RX Yes Yes ⤷  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

International Patents for sodium phenylbutyrate; taurursodiol

Country Patent Number Title Estimated Expiration
Japan 2019123721 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 (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF) ⤷  Sign Up
European Patent Office 3750531 COMPOSITIONS POUR AMÉLIORER LA VIABILITÉ CELLULAIRE ET LEURS PROCÉDÉS D'UTILISATION (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF) ⤷  Sign Up
Poland 2978419 ⤷  Sign Up
Mexico 2022007275 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sodium phenylbutyrate; taurursodiol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1856135 2020/017 Ireland ⤷  Sign Up 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
1948158 16C0018 France ⤷  Sign Up 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
1259550 08C0052 France ⤷  Sign Up PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
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
>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.