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Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. There are twenty-seven patents protecting this drug.
This drug has one hundred and thirty-eight patent family members in twenty-seven countries.
The generic ingredient in GALAFOLD is migalastat hydrochloride. Additional details are available on the migalastat hydrochloride profile page.
Galafold will be eligible for patent challenges on August 10, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 10, 2025. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
DrugPatentWatch® Estimated Generic Entry Opportunity Date for GALAFOLD
Generic Entry Date for GALAFOLD*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF ADULTS WITH A CONFIRMED DIAGNOSIS OF FABRY DISEASE AND AN AMENABLE GALACTOSIDASE ALPHA GENE (GLA) VARIANT BASED ON IN VITRO ASSAY DATA
*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.
Recent Clinical Trials for GALAFOLD
Identify potential brand extensions & 505(b)(2) entrants
|Amicus Therapeutics||Phase 3|
|Amicus Therapeutics||Phase 2|
|Country||Patent Number||Estimated Expiration|
|Hungary||E026543||⤷ Free Forever Trial|
|Australia||2021218172||⤷ Free Forever Trial|
|Poland||2533050||⤷ Free Forever Trial|
|Poland||2787345||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|2787345||2016/050||Ireland||⤷ Free Forever Trial||PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT; REGISTRATION NO/DATE: EU/1/15/1082 20160526|
|2787345||53/2016||Austria||⤷ Free Forever Trial||PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082 (MITTEILUNG) 20160531|
|2787345||1690052-4||Sweden||⤷ Free Forever Trial||PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REG. NO/DATE: EU/1/15/1082 20160531|
|2787345||C20160037 00206||Estonia||⤷ Free Forever 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|