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 thirty-one patent family members in thirty countries.
One supplier is listed for this compound.
Summary for MIGALASTAT HYDROCHLORIDE
International Patents: | 231 |
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 |
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 |
---|---|---|---|
Eurasian Patent Organization | 201992869 | СПОСОБЫ ЛЕЧЕНИЯ ПАЦИЕНТОВ С БОЛЕЗНЬЮ ФАБРИ, У КОТОРЫХ ИМЕЕТСЯ ПОЧЕЧНАЯ НЕДОСТАТОЧНОСТЬ | ⤷ Try a Trial |
European Patent Office | 3487502 | TRAITEMENT DE LA MALADIE DE FABRY CHEZ DES PATIENTS SOUMIS À UNE THÉRAPIE ENZYMATIQUE SUBSTITUTIVE (ERT) ET CHEZ DES PATIENTS NON SOUMIS À UNE ERT (TREATMENT OF FABRY DISEASE IN ERT-NAÏVE AND ERT-EXPERIENCED PATIENTS) | ⤷ Try a Trial |
Japan | 2023052005 | 腎機能障害を有するファブリー患者の治療方法 | ⤷ Try a Trial |
South Korea | 20240017111 | 신장 손상을 갖는 파브리 환자를 치료하는 방법 (METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT) | ⤷ Try a Trial |
Croatia | P20201827 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2017165164 | ⤷ Try a Trial | |
European Patent Office | 3470077 | PROCÉDÉ DE PRÉDICTION DE LA RÉACTION À UN TRAITEMENT DE MALADIES PAR CHAPERONS PHARMACOLOGIQUES (METHOD TO PREDICT RESPONSE TO PHARMACOLOGICAL CHAPERONE TREATMENT OF DISEASES) | ⤷ 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 | 634 | Finland | ⤷ Try a Trial | |
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 |
2787345 | 122016000090 | Germany | ⤷ Try a Trial | PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082/001 20160526 |
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 | PA2016033 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526 |
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 | PA2016033,C2787345 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |