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Last Updated: March 28, 2024

ZAVESCA Drug Patent Profile


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When do Zavesca patents expire, and when can generic versions of Zavesca launch?

Zavesca is a drug marketed by Actelion and is included in one NDA.

The generic ingredient in ZAVESCA 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 Zavesca

A generic version of ZAVESCA was approved as miglustat by ANI PHARMS on April 17th, 2018.

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Drug patent expirations by year for ZAVESCA
Drug Prices for ZAVESCA

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Recent Clinical Trials for ZAVESCA

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SponsorPhase
ActelionPhase 4
Tehran University of Medical SciencesPhase 3
Mashhad University of Medical SciencesPhase 3

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Pharmacology for ZAVESCA

US Patents and Regulatory Information for ZAVESCA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion ZAVESCA miglustat CAPSULE;ORAL 021348-001 Jul 31, 2003 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ZAVESCA

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 ZAVESCA

See the table below for patents covering ZAVESCA around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 9830219 ⤷  Try a Trial
Japan 3636363 ⤷  Try a Trial
Portugal 1007043 ⤷  Try a Trial
European Patent Office 1491196 ⤷  Try a Trial
Spain 2223118 ⤷  Try a Trial
Australia 5813898 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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