Amylyx Company Profile
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What is the competitive landscape for AMYLYX, and when can generic versions of AMYLYX drugs launch?
AMYLYX has one approved drug.
There are five US patents protecting AMYLYX drugs.
There are forty-nine patent family members on AMYLYX drugs in twenty-four countries and sixty-seven supplementary protection certificates in eight countries.
Drugs and US Patents for Amylyx
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 | 11,071,742 | ⤷ 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 | |||||
Amylyx | RELYVRIO | sodium phenylbutyrate; taurursodiol | FOR SUSPENSION;ORAL | 216660-001 | Sep 29, 2022 | RX | Yes | Yes | 10,251,896 | ⤷ Sign Up | ⤷ Sign Up | ||||
Amylyx | RELYVRIO | sodium phenylbutyrate; taurursodiol | FOR SUSPENSION;ORAL | 216660-001 | Sep 29, 2022 | RX | Yes | Yes | 9,872,865 | ⤷ Sign Up | ⤷ Sign Up | ||||
Amylyx | RELYVRIO | sodium phenylbutyrate; taurursodiol | FOR SUSPENSION;ORAL | 216660-001 | Sep 29, 2022 | RX | Yes | Yes | 10,857,162 | ⤷ 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 Amylyx Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Canada | 3161245 | ⤷ Sign Up |
China | 109999043 | ⤷ Sign Up |
Montenegro | 03747 | ⤷ Sign Up |
South Korea | 102607635 | ⤷ Sign Up |
Poland | 2978419 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amylyx Drugs
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.