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Last Updated: July 13, 2020

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GALAFOLD Drug Profile


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When do Galafold patents expire, and when can generic versions of Galafold launch?

Galafold is a drug marketed by Amicus Theraps Us and is included in one NDA. There are twelve patents protecting this drug.

This drug has one hundred and fourteen patent family members in twenty-six countries.

The generic ingredient in GALAFOLD is migalastat hydrochloride. Additional details are available on the migalastat hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Galafold

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

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Summary for GALAFOLD
International Patents:114
US Patents:12
Applicants:1
NDAs:1
Bulk Api Vendors: 13
Clinical Trials: 2
Patent Applications: 45
DailyMed Link:GALAFOLD at DailyMed
Drug patent expirations by year for GALAFOLD
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
NDA:
Dosage:
CAPSULE;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.

Recent Clinical Trials for GALAFOLD

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Amicus TherapeuticsPhase 3

See all GALAFOLD clinical trials

US Patents and Regulatory Information for GALAFOLD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for GALAFOLD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2787345 PA2016033,C2787345 Lithuania   Start Trial PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345 122016000090 Germany   Start Trial PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082/001 20160526
2787345 PA2016033 Lithuania   Start Trial PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 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 16C1014 France   Start Trial PRODUCT NAME: MIGALASTAT OU UN SEL DE CELUI-CI,NOTAMENT LE CHLORHYDRATE; REGISTRATION NO/DATE: EU1/15/1082 20160531
2787345 1690052-4 Sweden   Start Trial PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REG. NO/DATE: EU/1/15/1082 20160531
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Dow
McKinsey
Harvard Business School
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.