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Last Updated: November 5, 2024

MIGLUSTAT - Generic Drug Details


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What are the generic drug sources for miglustat and what is the scope of patent protection?

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-seven 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:137
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
Drug Prices for MIGLUSTAT

See drug prices for MIGLUSTAT

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

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
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
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

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

Supplementary Protection Certificates for MIGLUSTAT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3201320 LUC00336 Luxembourg ⤷  Sign Up PRODUCT NAME: CIPAGLUCOSIDASE ALFA; AUTHORISATION NUMBER AND DATE: EU/1/22/1714 20230324
3201320 CA 2024 00012 Denmark ⤷  Sign Up PRODUCT NAME: CIPAGLUCOSIDASE ALFA; REG. NO/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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