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Last Updated: November 22, 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 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
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 ⤷  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
Canada 3161245 ⤷  Sign Up
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) ⤷  Sign Up
Montenegro 03747 KOMPOZICIJE ZA POBOLJŠANJE ĆELIJSKE VIJABILNOSTI I POSTUPCI ZA NJIHOVU UPOTREBU (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF) ⤷  Sign Up
South Korea 102607635 ⤷  Sign Up
Poland 2978419 ⤷  Sign Up
Japan 2022122929 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 ⤷  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
1912999 1490062-5 Sweden ⤷  Sign Up PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
1856135 CA 2020 00018 Denmark ⤷  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; REG. NO/DATE: EU/1/19/1405 20200113
2822954 LUC00083 Luxembourg ⤷  Sign Up PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
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
1948158 1690020-1 Sweden ⤷  Sign Up PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
1912999 2014/058 Ireland ⤷  Sign Up PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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