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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
|---|---|---|---|
| European Patent Office | 2150254 | SCHÉMAS POSOLOGIQUES POUR LE TRAITEMENT DE MALADIES DE STOCKAGE LYSOSOMAL EN UTILISANT DES CHAPERONS PHARMACOLOGIQUES (DOSING REGIMENS FOR THE TREATMENT OF LYSOSOMAL STORAGE DISEASES USING PHARMACOLOGICAL CHAPERONES) | ⤷ Try a Trial |
| Hong Kong | 1218955 | 法布瑞氏症的治療選項 (TREATMENT OPTIONS FOR FABRY DISEASE) | ⤷ Try a Trial |
| Israel | 290365 | שיטות לטיפול במחלת פברי בחולים בעלי מוטציה בגן gla (Methods of treating fabry disease in patients having a mutation in the gla gene) | ⤷ Try a Trial |
| Canada | 3224529 | METHODES DE TRAITEMENT DE PATIENTS ATTEINTS DE LA MALADIE DE FABRY SOUFFRANT D'UNE INSUFFISANCE RENALE (METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT) | ⤷ Try a Trial |
| Japan | 7175297 | ⤷ Try a Trial | |
| South Korea | 20240017111 | 신장 손상을 갖는 파브리 환자를 치료하는 방법 (METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT) | ⤷ 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 | 1690052-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REG. NO/DATE: EU/1/15/1082 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 | 132016000116282 | Italy | ⤷ Try a Trial | PRODUCT NAME: MIGALASTAT O UN SUO SALE, COMPRESO IL SALE CLORIDRATO(GALAFOLD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1082, 20160531 |
| 2787345 | 634 | Finland | ⤷ Try a Trial | |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
