ZAVESCA Drug Patent Profile

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 17^th, 2018.

Summary for ZAVESCA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	12
Patent Applications:	1,952
Drug Prices:	Drug price information for ZAVESCA
What excipients (inactive ingredients) are in ZAVESCA?	ZAVESCA excipients list
DailyMed Link:	ZAVESCA at DailyMed

See drug prices for ZAVESCA

Recent Clinical Trials for ZAVESCA

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

Sponsor	Phase
Actelion	Phase 4
Mashhad University of Medical Sciences	Phase 3
Kashan University of Medical Sciences	Phase 3

See all ZAVESCA clinical trials

Pharmacology for ZAVESCA

Drug Class	Glucosylceramide Synthase Inhibitor
Mechanism of Action	Glucosylceramide Synthase Inhibitors

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

Expired US Patents for ZAVESCA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Actelion	ZAVESCA	miglustat	CAPSULE;ORAL	021348-001	Jul 31, 2003
Actelion	ZAVESCA	miglustat	CAPSULE;ORAL	021348-001	Jul 31, 2003

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

International Patents for ZAVESCA

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

Country	Patent Number	Title	Estimated Expiration
Germany	69401658
Austria	268598
Spain	2097653