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 thirty-seven patent family members in forty-one 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.
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Summary for OPFOLDA
| International Patents: | 137 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| 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 | Enzyme Stabilizer Glucosylceramide Synthase Inhibitor |
| Mechanism of Action | Enzyme Stabilizers Glucosylceramide Synthase Inhibitors |
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 | |||
| >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 |
|---|---|---|---|
| Japan | 2024105244 | ポンペ病の処置のための高濃度α－グルコシダーゼ組成物 | ⤷ Sign Up |
| South Korea | 20140135222 | HIGH CONCENTRATION ALPHA-GLUCOSIDASE COMPOSITIONS FOR THE TREATMENT OF POMPE DISEASE | ⤷ Sign Up |
| Canada | 2866683 | COMPOSITIONS D'ALPHA-GLUCOSIDASE A HAUTE CONCENTRATION POUR LE TRAITEMENT DE LA MALADIE DE POMPE (HIGH CONCENTRATION ALPHA-GLUCOSIDASE COMPOSITIONS FOR THE TREATMENT OF POMPE DISEASE) | ⤷ Sign Up |
| Cyprus | 1124637 | ⤷ Sign Up | |
| Croatia | P20231465 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OPFOLDA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3201320 | PA2024509 | Lithuania | ⤷ Sign Up | PRODUCT NAME: CIPAGLIUKOZIDAZE ALFA; REGISTRATION NO/DATE: EU/1/22/1714 20230320 |
| 3201320 | 122024000016 | Germany | ⤷ Sign Up | PRODUCT NAME: CIPAGLUCOSIDASE ALFA; REGISTRATION NO/DATE: EU/1/22/1714 20230320 |
| 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 | 301267 | Netherlands | ⤷ Sign Up | PRODUCT NAME: POMBILITI (CIPAGLUCOSIDASE ALFA); REGISTRATION NO/DATE: EU/1/22/1714 20230324 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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