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
Drug Class | Nitrogen Binding Agent |
Mechanism of Action | Ammonium Ion Binding Activity |
Anatomical Therapeutic Chemical (ATC) Classes 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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