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 Therap Us and is included in one NDA. There are forty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Migalastat hydrochloride has one hundred and fifty-nine patent family members in twenty-seven countries.
One supplier is listed for this compound.
Summary for MIGALASTAT HYDROCHLORIDE
| International Patents: | 159 |
| US Patents: | 46 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 84 |
| Clinical Trials: | 20 |
| Patent Applications: | 225 |
| 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 |
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 | ⤷ 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 | ||||
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 |
|---|---|---|---|
| Australia | 2017298376 | Treatment of Fabry disease in ERT-naive and ERT-experienced patients | ⤷ Sign Up |
| European Patent Office | 2252313 | MÉTHODE DE PRÉDICTION DE LA RÉPONSE DE CERTAINES MALADIES À UN TRAITEMENT PHARMACOLOGIQUE À BASE DE CHAPERONE MOLÉCULAIRE (METHOD TO PREDICT RESPONSE TO PHARMACOLOGICAL CHAPERONE TREATMENT OF DISEASES) | ⤷ Sign Up |
| Croatia | P20201827 | ⤷ Sign Up | |
| Japan | 2016163571 | 疾病の薬理シャペロン治療に対する応答性を予測する方法 (METHOD OF PREDICTING RESPONSE TO PHARMACOLOGICAL CHAPERONE TREATMENT OF DISEASES) | ⤷ 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 | CA 2016 00055 | Denmark | ⤷ Sign Up | PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531 |
| 2787345 | C 2016 042 | Romania | ⤷ Sign Up | 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 | 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 | C02787345/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: MIGALASTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66108 28.10.2016 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
