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Migalastat hydrochloride - Generic Drug Details
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What are the generic drug sources for migalastat hydrochloride and what is the scope of patent protection?
Migalastat hydrochloride
is the generic ingredient in one branded drug marketed by Amicus Theraps Us and is included in one NDA. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.Migalastat hydrochloride has one hundred and twenty-eight patent family members in twenty-six countries.
Summary for migalastat hydrochloride
International Patents: | 128 |
US Patents: | 21 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Bulk Api Vendors: | 26 |
Clinical Trials: | 16 |
Patent Applications: | 3 |
What excipients (inactive ingredients) are in migalastat hydrochloride? | migalastat hydrochloride excipients list |
DailyMed Link: | migalastat hydrochloride at DailyMed |
Recent Clinical Trials for migalastat hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Amicus Therapeutics | Phase 1 |
Amicus Therapeutics | Phase 3 |
Amicus Therapeutics | Phase 2 |
US Patents and Regulatory Information for migalastat hydrochloride
International Patents for migalastat hydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
Australia | 2019219727 | Start Trial |
Australia | 2009214648 | Start Trial |
Denmark | 2946785 | Start Trial |
Japan | 2010525084 | Start Trial |
Luxembourg | 93312 | Start Trial |
Japan | 2011514152 | Start Trial |
Australia | 2014221321 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for migalastat hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2787345 | 53/2016 | Austria | Start Trial | PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082 (MITTEILUNG) 20160531 |
2787345 | C02787345/01 | Switzerland | Start Trial | PRODUCT NAME: MIGALASTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66108 28.10.2016 |
2787345 | 268 5025-2016 | Slovakia | Start Trial | PRODUCT NAME: MIGALASTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1082 20160531 |
2787345 | 2016/050 | Ireland | Start Trial | PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT; REGISTRATION NO/DATE: EU/1/15/1082 20160526 |
2787345 | C 2016 042 | Romania | Start Trial | 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 | CR 2016 00055 | Denmark | Start Trial | PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531 |
2787345 | C20160037 00206 | Estonia | Start Trial | PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |