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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 Theraps Us and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Migalastat hydrochloride has one hundred and fourteen patent family members in twenty-six countries.
Summary for migalastat hydrochloride
| International Patents: | 114 |
| US Patents: | 12 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 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 |
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 | ||||
| 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 |
|---|---|---|
| Portugal | 2252313 | Start Trial |
| Croatia | P20150728 | Start Trial |
| Australia | 2016206297 | Start Trial |
| Israel | 201733 | Start Trial |
| Hong Kong | 1178975 | 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 | 132016000116282 | Italy | Start 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 | 93312 | Luxembourg | Start 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 | 1690052-4 | Sweden | Start Trial | PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REG. NO/DATE: EU/1/15/1082 20160531 |
| 2787345 | 16C1014 | France | Start Trial | PRODUCT NAME: MIGALASTAT OU UN SEL DE CELUI-CI,NOTAMENT LE CHLORHYDRATE; REGISTRATION NO/DATE: EU1/15/1082 20160531 |
| 2787345 | 2016/050 | Ireland | Start Trial | PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT; REGISTRATION NO/DATE: EU/1/15/1082 20160526 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
