AMICUS THERAP US Company Profile
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What is the competitive landscape for AMICUS THERAP US, and what generic alternatives to AMICUS THERAP US drugs are available?
AMICUS THERAP US has two approved drugs.
There are sixty-five US patents protecting AMICUS THERAP US drugs.
There are three hundred and twenty-two patent family members on AMICUS THERAP US drugs in forty-three countries and twenty-four supplementary protection certificates in seventeen countries.
Summary for AMICUS THERAP US
International Patents: | 322 |
US Patents: | 65 |
Tradenames: | 2 |
Ingredients: | 2 |
NDAs: | 2 |
Drugs and US Patents for AMICUS THERAP US
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | 11,033,538 | ⤷ Sign Up | ⤷ Sign Up | ||||
Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | 11,753,632 | ⤷ Sign Up | ⤷ Sign Up | ||||
Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | 10,925,866 | ⤷ Sign Up | ⤷ Sign Up | ||||
Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | 11,826,360 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | 11,278,601 | ⤷ Sign Up | Y | ⤷ 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 AMICUS THERAP US Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Lithuania | 2946785 | ⤷ Sign Up |
Taiwan | 201726163 | ⤷ Sign Up |
Spain | 2541933 | ⤷ Sign Up |
Japan | 2023052005 | ⤷ Sign Up |
South Korea | 20240017112 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AMICUS THERAP US Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2787345 | C 2016 042 | Romania | ⤷ Sign Up | PRODUCT NAME: MIGALASTAT SAU O SARE A ACESTUIA, INCLUSIV SAREACLORHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/15/1082; DATE OF NATIONAL AUTHORISATION: 20160526; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1082; DATE OF FIRST AUTHORISATION IN EEA: 20160526 |
2787345 | C02787345/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: MIGALASTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66108 28.10.2016 |
3201320 | 122024000016 | Germany | ⤷ Sign Up | PRODUCT NAME: CIPAGLUCOSIDASE ALFA; REGISTRATION NO/DATE: EU/1/22/1714 20230320 |
2787345 | CA 2016 00055 | Denmark | ⤷ Sign Up | PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531 |
2787345 | 2016/050 | Ireland | ⤷ Sign Up | PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT; REGISTRATION NO/DATE: EU/1/15/1082 20160526 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.