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Last Updated: November 5, 2024

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
Drug patent expirations by year for MIGLUSTAT
Drug Prices for MIGLUSTAT

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Recent Clinical Trials for MIGLUSTAT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Beyond Batten Disease FoundationPhase 1/Phase 2
TheranexusPhase 1/Phase 2
University of OxfordPhase 2

See all MIGLUSTAT clinical trials

Pharmacology 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

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