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 Therap Us and is included in one NDA. There are sixty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Migalastat hydrochloride has two hundred and forty patent family members in thirty countries.
One supplier is listed for this compound.
Summary for migalastat hydrochloride
| International Patents: | 240 |
| US Patents: | 62 |
| 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for migalastat hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | 201733581 | Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene | ⤷ Sign Up |
| Japan | 2022130589 | ＧＬＡ遺伝子にＧ９３３１Ａ変異を有する患者においてファブリー病を処置する方法 | ⤷ Sign Up |
| European Patent Office | 4062915 | MIGALASTAT ATTACHÉ À ALPHA GALACTOSIDASE A (MIGALASTAT BOUND TO ALPHA GALACTOSIDASE A) | ⤷ Sign Up |
| European Patent Office | 3630114 | MÉTHODES DE TRAITEMENT DE PATIENTS ATTEINTS DE LA MALADIE DE FABRY SOUFFRANT D'UNE INSUFFISANCE RÉNALE (METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT) | ⤷ Sign Up |
| Japan | 2022033749 | ＥＲＴナイーブ患者及びＥＲＴ経験患者におけるファブリー病の処置 | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for migalastat hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2787345 | 53/2016 | Austria | ⤷ Sign Up | PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082 (MITTEILUNG) 20160531 |
| 2787345 | C02787345/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: MIGALASTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66108 28.10.2016 |
| 2787345 | 2016/050 | Ireland | ⤷ Sign Up | PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT; REGISTRATION NO/DATE: EU/1/15/1082 20160526 |
| 2787345 | 1690052-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REG. NO/DATE: EU/1/15/1082 20160531 |
| 2787345 | 300843 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
