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Migalastat hydrochloride - Generic Drug Details
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What are the generic 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 Theraps Us and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Migalastat hydrochloride has one hundred and three patent family members in twenty-five countries.
One supplier is listed for this compound.
Summary for migalastat hydrochloride
| International Patents: | 103 |
| US Patents: | 11 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 25 |
| Clinical Trials: | 16 |
| Patent Applications: | 3 |
| DailyMed Link: | migalastat hydrochloride at DailyMed |
Recent Clinical Trials for migalastat hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Amicus Therapeutics | Phase 1 |
| Amicus Therapeutics | Phase 3 |
| Amicus Therapeutics | Phase 2 |
Synonyms for migalastat hydrochloride
| (+)-(2R,3S,4R,5S)-2-(Hydroxymethyl)piperidine-3,4,5-triol hydrochloride |
| (2R,3S,4R,5S)-2-(hydroxymethyl)-3,4,5-Piperidinetriol hydrochloride |
| (2R,3S,4R,5S)-2-(Hydroxymethyl)piperidine-3,4,5-triol hydrochloride |
| 1-Deoxygalactonojirimycin HCl |
| 1-Deoxynojirimycin hydrochloride |
| 1,5-Dideoxy-1,5-imino-D-galactitol |
| 1,5-dideoxy-1,5-imino-d-galactitol hydrochloride |
| 108147-54-2 |
| 3,4,5-Piperidinetriol, 2-(hydroxymethyl)-, hydrochloride, (2R,3S,4R,5S)- |
| 3,4,5-Piperidinetriol, 2-(hydroxymethyl)-, hydrochloride,[2R-(2a,3a,4a,5b)]- |
| 75172-81-5 |
| Amigal |
| BICL4269 |
| CHEMBL2107355 |
| CLY7M0XD20 |
| CS-6380 |
| D05031 |
| Deoxygalactonojirimycin hydrochloride |
| DEOXYGALACTONOJIRIMYCIN,HYDROCHLORIDE |
| FT-0665818 |
| Galafold (TN) |
| HY-14929A |
| Migalastat (hydrochloride) |
| Migalastat hydrochloride (JAN/USAN) |
| Migalastat Hydrochloride [USAN] |
| OR2365T |
| SB18975 |
| SCHEMBL3802618 |
| UNII-CLY7M0XD20 |
| W-203722 |
| ZX-AT009958 |
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 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 |
International Patents for migalastat hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | S1600048 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2009102895 | Start Trial |
| Canada | 2652553 | Start Trial |
| Japan | 2009537149 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for migalastat hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2787345 | C02787345/01 | Switzerland | Start Trial | PRODUCT NAME: MIGALASTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66108 28.10.2016 |
| 2787345 | 300843 | Netherlands | Start Trial | PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531 |
| 2787345 | C 2016 042 | Romania | Start 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 | 53/2016 | Austria | Start Trial | PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082 (MITTEILUNG) 20160531 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
