Miglustat - Generic Drug Details
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What are the generic drug sources for miglustat and what is the scope of freedom to operate?
Miglustat
is the generic ingredient in four branded drugs marketed by Ani Pharms, Breckenridge, Amicus Therap Us, Edenbridge Pharms, and Actelion, and is included in five NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Miglustat has one hundred and thirty-six patent family members in forty-one countries.
There are two drug master file entries for miglustat. Five suppliers are listed for this compound.
Summary for miglustat
International Patents: | 136 |
US Patents: | 7 |
Tradenames: | 4 |
Applicants: | 5 |
NDAs: | 5 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 29 |
Patent Applications: | 3,071 |
Drug Prices: | Drug price trends for miglustat |
What excipients (inactive ingredients) are in miglustat? | miglustat excipients list |
DailyMed Link: | miglustat at DailyMed |
Recent Clinical Trials for miglustat
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Beyond Batten Disease Foundation | Phase 1/Phase 2 |
Theranexus | Phase 1/Phase 2 |
University of Oxford | Phase 2 |
Pharmacology for miglustat
Drug Class | Glucosylceramide Synthase Inhibitor Enzyme Stabilizer |
Mechanism of Action | Glucosylceramide Synthase Inhibitors Enzyme Stabilizers |
Anatomical Therapeutic Chemical (ATC) Classes for miglustat
US Patents and Regulatory Information for miglustat
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 | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Breckenridge | MIGLUSTAT | miglustat | CAPSULE;ORAL | 209325-001 | Feb 3, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | 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 |
Expired US Patents for miglustat
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Actelion | ZAVESCA | miglustat | CAPSULE;ORAL | 021348-001 | Jul 31, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Actelion | ZAVESCA | miglustat | CAPSULE;ORAL | 021348-001 | Jul 31, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for miglustat
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Piramal Critical Care B.V. | Yargesa | miglustat | EMEA/H/C/004016 Yargesa is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.Yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.Yargesa is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease. |
Authorised | yes | no | no | 2017-03-22 | |
Janssen Cilag International NV | Zavesca | miglustat | EMEA/H/C/000435 Zavesca is indicated for the oral treatment of adult patients with mild to moderate type-1 Gaucher disease. Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type-C disease. |
Authorised | no | no | no | 2002-11-20 | 2009-06-16 |
Gen.Orph | Miglustat Gen.Orph | miglustat | EMEA/H/C/004366 Miglustat Gen.Orph is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Miglustat Gen.Orph may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.Miglustat Gen.Orph is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease. |
Authorised | yes | no | no | 2017-11-09 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for miglustat
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ecuador | SP17019103 | ALFA-GLUCOSIDASA ÁCIDA MUY POTENTE CON HIDRATOS DE CARBONO POTENCIADOS | ⤷ Sign Up |
Singapore | 10202003753P | HIGHLY POTENT ACID ALPHA-GLUCOSIDASE WITH ENHANCED CARBOHYDRATES | ⤷ Sign Up |
Israel | 289383 | אלפא-גלוקוסידאז חומצי עם חוזק גבוה בעל פחממות משופרות (Highly potent acid alpha-glucosidase with enhanced carbohydrates) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for miglustat
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3201320 | CA 2024 00012 | Denmark | ⤷ Sign Up | PRODUCT NAME: CIPAGLUCOSIDASE ALFA; REG. NO/DATE: EU/1/22/1714 20230324 |
3201320 | LUC00336 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: CIPAGLUCOSIDASE ALFA; AUTHORISATION NUMBER AND DATE: EU/1/22/1714 20230324 |
3201320 | 122024000016 | Germany | ⤷ Sign Up | PRODUCT NAME: CIPAGLUCOSIDASE ALFA; REGISTRATION NO/DATE: EU/1/22/1714 20230320 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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