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 twelve patent family members in forty countries.
There are two drug master file entries for miglustat. Five suppliers are listed for this compound.
Summary for miglustat
International Patents: | 112 |
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: | 3,353 |
Formulation / Manufacturing: | see details |
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 |
Mechanism of Action | Glucosylceramide Synthase Inhibitors |
US Patents and Regulatory Information for miglustat
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Actelion | ZAVESCA | miglustat | CAPSULE;ORAL | 021348-001 | Jul 31, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 | |
Dipharma Arzneimittel GmbH | Miglustat Dipharma | miglustat | EMEA/H/C/004904 Miglustat Dipharma is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.Miglustat Dipharma may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.Miglustat Dipharma 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 | 2019-02-18 | |
Amicus Therapeutics Europe Limited | Opfolda | miglustat | EMEA/H/C/005695 Opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset Pompe disease (acid α- glucosidase [GAA] deficiency). |
Authorised | no | no | no | 2023-06-26 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for miglustat
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 038986 | ВЫСОКОАКТИВНАЯ КИСЛАЯ АЛЬФА-ГЛЮКОЗИДАЗА С ПОВЫШЕННЫМ СОДЕРЖАНИЕМ УГЛЕВОДОВ (HIGHLY POTENT ACID ALPHA-GLUCOSIDASE WITH ENHANCED CARBOHYDRATES) | ⤷ Try a Trial |
South Korea | 102455814 | ⤷ Try a Trial | |
European Patent Office | 3397273 | ALPHA-GLUCOSIDASE ACIDE AMÉLIORÉE POUR LE TRAITEMENT DE LA MALADIE DE POMPE (AUGMENTED ACID ALPHA-GLUCOSIDASE FOR THE TREATMENT OF POMPE DISEASE) | ⤷ Try a Trial |
Japan | 2022058423 | ポンペ病の処置のための強化酸性アルファ-グルコシダーゼ | ⤷ Try a Trial |
Japan | 2017537604 | 炭水化物が増大している非常に強力な酸性アルファ−グルコシダーゼ | ⤷ Try a Trial |
Colombia | 2017002776 | Composición de alfa glucosidasa humana recombinante y métodos para su fabricación | ⤷ Try a Trial |
South Korea | 20180099753 | 폼페병 치료용의 강화된 산 알파-글루코시다제 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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