Migalastat hydrochloride - Generic Drug Details
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What are the generic drug sources for migalastat hydrochloride and what is the scope of freedom to operate?
Migalastat hydrochloride
is the generic ingredient in one branded drug marketed by Amicus Therap Us and is included in one NDA. There are fifty-eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Migalastat hydrochloride has two hundred and twenty-one patent family members in twenty-nine countries.
One supplier is listed for this compound.
Summary for migalastat hydrochloride
| International Patents: | 221 |
| US Patents: | 58 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 41 |
| Clinical Trials: | 20 |
| Patent Applications: | 163 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for migalastat hydrochloride |
| What excipients (inactive ingredients) are in migalastat hydrochloride? | migalastat hydrochloride excipients list |
| DailyMed Link: | migalastat hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for migalastat hydrochloride
Generic Entry Date for migalastat hydrochloride*:
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 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 migalastat hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Genzyme, a Sanofi Company | Phase 3 |
| Amicus Therapeutics | Phase 1 |
| Amicus Therapeutics | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for migalastat hydrochloride
Paragraph IV (Patent) Challenges for MIGALASTAT HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| GALAFOLD | Capsules | migalastat hydrochloride | 123 mg | 208623 | 3 | 2022-08-10 |
US Patents and Regulatory Information for migalastat hydrochloride
International Patents for migalastat hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | 201806597 | Treatment of Fabry disease in ERT-naive and ERT-experienced patients | ⤷ Try a Trial |
| Denmark | 2252313 | ⤷ Try a Trial | |
| South Korea | 20240017110 | 신장 손상을 갖는 파브리 환자를 치료하는 방법 (METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT) | ⤷ Try a Trial |
| Argentina | 111971 | MÉTODOS PARA TRATAR PACIENTES CON ENFERMEDAD DE FABRY QUE TIENEN INSUFICIENCIA RENAL | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2007137072 | ⤷ Try a Trial | |
| Japan | 5844045 | ⤷ Try a Trial | |
| South Korea | 20220152547 | GLA 유전자에 돌연변이를 갖는 환자에서 파브리 질병을 치료하는 방법 | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for migalastat hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2787345 | SPC/GB16/067 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REGISTERED: UK EU/1/15/1082/001 20160531 |
| 2787345 | 53/2016 | Austria | ⤷ Try a Trial | PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082 (MITTEILUNG) 20160531 |
| 2787345 | 93312 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: MIGALASTAT OU UN SEL DE CELUI-CI , Y COMPRIS LE SEL DE CHLORHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1082 - GALAFOLD - MIGALASTAT |
| 2787345 | CA 2016 00055 | Denmark | ⤷ Try a Trial | PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531 |
| 2787345 | 268 5025-2016 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: MIGALASTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1082 20160531 |
| 2787345 | C20160037 00206 | Estonia | ⤷ Try a Trial | PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016 |
| 2787345 | C 2016 042 | Romania | ⤷ Try a 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
