MIGLUSTAT Drug Patent Profile
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Which patents cover Miglustat, and what generic alternatives are available?
Miglustat is a drug marketed by Ani Pharms and Breckenridge and is included in two NDAs.
The generic ingredient in MIGLUSTAT is miglustat. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the miglustat profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Miglustat
A generic version of MIGLUSTAT was approved as miglustat by ANI PHARMS on April 17th, 2018.
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Summary for MIGLUSTAT
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 29 |
| Patent Applications: | 1,952 |
| Drug Prices: | Drug price information 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 |
|---|---|
| Theranexus | Phase 1/Phase 2 |
| Beyond Batten Disease Foundation | Phase 1/Phase 2 |
| University of Oxford | Phase 2 |
Pharmacology for MIGLUSTAT
| Drug Class | Glucosylceramide Synthase Inhibitor |
| Mechanism of Action | Glucosylceramide Synthase Inhibitors |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | MIGLUSTAT | miglustat | CAPSULE;ORAL | 208342-001 | Apr 17, 2018 | AB | RX | No | No | ⤷ 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 |
