Miglustat - Generic Drug Details

What are the generic drug sources for miglustat and what is the scope of freedom to operate?

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

See drug prices for miglustat

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

See all miglustat clinical trials

Pharmacology for miglustat

Drug Class	Glucosylceramide Synthase Inhibitor Enzyme Stabilizer
Mechanism of Action	Glucosylceramide Synthase Inhibitors Enzyme Stabilizers

Anatomical Therapeutic Chemical (ATC) Classes for miglustat

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

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
Amicus Therap Us	OPFOLDA	miglustat	CAPSULE;ORAL	215211-001	Sep 28, 2023		RX	Yes	Yes
Breckenridge	MIGLUSTAT	miglustat	CAPSULE;ORAL	209325-001	Feb 3, 2022		DISCN	No	No
Amicus Therap Us	OPFOLDA	miglustat	CAPSULE;ORAL	215211-001	Sep 28, 2023		RX	Yes	Yes			Y	Y
Amicus Therap Us	OPFOLDA	miglustat	CAPSULE;ORAL	215211-001	Sep 28, 2023		RX	Yes	Yes
Actelion	ZAVESCA	miglustat	CAPSULE;ORAL	021348-001	Jul 31, 2003	AB	RX	Yes	Yes
Ani Pharms	MIGLUSTAT	miglustat	CAPSULE;ORAL	208342-001	Apr 17, 2018	AB	RX	No	No
Amicus Therap Us	OPFOLDA	miglustat	CAPSULE;ORAL	215211-001	Sep 28, 2023		RX	Yes	Yes			Y

Expired US Patents for miglustat

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 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

International Patents for miglustat

Country	Patent Number	Title	Estimated Expiration
Mexico	2022010311	ALFA-GLUCOSIDASA CON MAYOR CANTIDAD DE ACIDO PARA EL TRATAMIENTO DE LA ENFERMEDAD DE POMPE. (AUGMENTED ACID ALPHA-GLUCOSIDASE FOR THE TREATMENT OF POMPE DISEASE.)
Mexico	2017003989	ALFA-GLUCOSIDASA ACIDA ALTAMENTE POTENTE CON CARBOHIDRATOS MEJORADOS. (HIGHLY POTENT ACID ALPHA-GLUCOSIDASE WITH ENHANCED CARBOHYDRATES.)
Argentina	107277	a-GLUCOSIDASA CON MAYOR CANTIDAD DE ÁCIDO PARA EL TRATAMIENTO DE LA ENFERMEDAD DE POMPE
Singapore	11201804965S	AUGMENTED ACID ALPHA-GLUCOSIDASE FOR THE TREATMENT OF POMPE DISEASE
Lithuania	3957320
Canada	2961762	ALPHA-GLUCOSIDASE ACIDE TRES PUISSANTE AYANT DES HYDRATES DE CARBONE AMELIORES (HIGHLY POTENT ACID ALPHA-GLUCOSIDASE WITH ENHANCED CARBOHYDRATES)
Denmark	3957320

Supplementary Protection Certificates for miglustat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3201320	122024000016	Germany		PRODUCT NAME: CIPAGLUCOSIDASE ALFA; REGISTRATION NO/DATE: EU/1/22/1714 20230320
3201320	LUC00336	Luxembourg		PRODUCT NAME: CIPAGLUCOSIDASE ALFA; AUTHORISATION NUMBER AND DATE: EU/1/22/1714 20230324
3201320	CA 2024 00012	Denmark		PRODUCT NAME: CIPAGLUCOSIDASE ALFA; REG. NO/DATE: EU/1/22/1714 20230324
3201320	301267	Netherlands		PRODUCT NAME: POMBILITI (CIPAGLUCOSIDASE ALFA); REGISTRATION NO/DATE: EU/1/22/1714 20230324
3201320	PA2024509	Lithuania		PRODUCT NAME: CIPAGLIUKOZIDAZE ALFA; REGISTRATION NO/DATE: EU/1/22/1714 20230320
3201320	2024C/513	Belgium		PRODUCT NAME: CIPAGLUCOSIDASE ALFA; AUTHORISATION NUMBER AND DATE: EU/1/22/1714 20230324