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 forty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.Migalastat hydrochloride has one hundred and forty-nine patent family members in twenty-seven countries.
Summary for migalastat hydrochloride
International Patents: | 149 |
US Patents: | 41 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 20 |
Patent Applications: | 183 |
What excipients (inactive ingredients) are in migalastat hydrochloride? | migalastat hydrochloride excipients list |
DailyMed Link: | migalastat hydrochloride at DailyMed |
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
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 |
---|---|---|---|
Hong Kong | 1129458 | 診斷和評估法布瑞氏病治療策略的檢測 (ASSAYS FOR DIAGNOSING AND EVALUATING TREATMENT OPTIONS FOR FABRY DISEASE) | See Plans and Pricing |
Colombia | 2018006358 | Tratamiento de la enfermedad de fabry en pacientes no tratados y tratados previamente con ert | See Plans and Pricing |
Luxembourg | 93312 | See Plans and Pricing | |
Taiwan | 201733581 | Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for migalastat hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2787345 | PA2016033,C2787345 | Lithuania | See Plans and Pricing | PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526 |
2787345 | C20160037 00206 | Estonia | See Plans and Pricing | PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016 |
2787345 | 300843 | Netherlands | See Plans and Pricing | PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531 |
2787345 | 122016000090 | Germany | See Plans and Pricing | PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082/001 20160526 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |