OPFOLDA Drug Patent Profile
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When do Opfolda patents expire, and what generic alternatives are available?
Opfolda is a drug marketed by Amicus Therap Us and is included in one NDA. There are seven patents protecting this drug.
This drug has one hundred and twenty-eight patent family members in forty countries.
The generic ingredient in OPFOLDA 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 Opfolda
A generic version of OPFOLDA was approved as miglustat by ANI PHARMS on April 17th, 2018.
Summary for OPFOLDA
International Patents: | 128 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for OPFOLDA |
What excipients (inactive ingredients) are in OPFOLDA? | OPFOLDA excipients list |
DailyMed Link: | OPFOLDA at DailyMed |
Pharmacology for OPFOLDA
Drug Class | Glucosylceramide Synthase Inhibitor |
Mechanism of Action | Glucosylceramide Synthase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for OPFOLDA
US Patents and Regulatory Information for OPFOLDA
OPFOLDA is protected by seven US patents and one FDA Regulatory Exclusivity.
Patents protecting OPFOLDA
Highly potent acid alpha-glucosidase with enhanced carbohydrates
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: THE TREATMENT OF POMPE PATIENTS
High concentration alpha-glucosidase compositions for the treatment of pompe disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: THE TREATMENT OF POMPE PATIENTS
Augmented acid alpha-glucosidase for the treatment of Pompe disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: THE TREATMENT OF POMPE PATIENTS
Highly potent acid alpha-glucosidase with enhanced carbohydrates
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: THE TREATMENT OF POMPE PATIENTS
High concentration alpha-glucosidase compositions for the treatment of Pompe disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: THE TREATMENT OF POMPE PATIENTS
Augmented acid alpha-glucosidase for the treatment of Pompe disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: THE TREATMENT OF POMPE PATIENTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: THE TREATMENT OF POMPE PATIENTS
FDA Regulatory Exclusivity protecting OPFOLDA
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
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 | ⤷ 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 | Y | Y | ⤷ 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 | ||||
Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 OPFOLDA
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 OPFOLDA
See the table below for patents covering OPFOLDA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 038986 | ВЫСОКОАКТИВНАЯ КИСЛАЯ АЛЬФА-ГЛЮКОЗИДАЗА С ПОВЫШЕННЫМ СОДЕРЖАНИЕМ УГЛЕВОДОВ (HIGHLY POTENT ACID ALPHA-GLUCOSIDASE WITH ENHANCED CARBOHYDRATES) | ⤷ Sign Up |
Denmark | 3201320 | ⤷ Sign Up | |
Ecuador | SP17019103 | ALFA-GLUCOSIDASA ÁCIDA MUY POTENTE CON HIDRATOS DE CARBONO POTENCIADOS | ⤷ Sign Up |
Singapore | 11201702114T | HIGHLY POTENT ACID ALPHA-GLUCOSIDASE WITH ENHANCED CARBOHYDRATES | ⤷ Sign Up |
Colombia | 2018007680 | Alfa-glucosidasa con mayor cantidad de ácido para el tratamiento de la enfermedad de pompe campo | ⤷ Sign Up |
South Korea | 20230041833 | 폼페병 치료용의 강화된 산 알파-글루코시다제 (-AUGMENTED ACID ALPHA-GLUCOSIDASE FOR THE TREATMENT OF POMPE DISEASE) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |