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 ten patents protecting this drug.
This drug has two hundred and twenty-four patent family members in forty-four countries.
The generic ingredient in OPFOLDA is miglustat. There are two drug master file entries for this compound. Seven 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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Questions you can ask:
- What is the 5 year forecast for OPFOLDA?
- What are the global sales for OPFOLDA?
- What is Average Wholesale Price for OPFOLDA?
Summary for OPFOLDA
| International Patents: | 224 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OPFOLDA |
US Patents and Regulatory Information for OPFOLDA
OPFOLDA is protected by ten US patents and one FDA Regulatory Exclusivity.
| 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 | 12,419,937 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | 10,961,522 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | 11,753,632 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | 10,857,212 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | 12,414,985 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | 12,246,062 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | 11,278,599 | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for OPFOLDA
See the table below for patents covering OPFOLDA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 102348 | ⤷ Start Trial | |
| Australia | 2015325028 | ⤷ Start Trial | |
| Australia | 2022203498 | ⤷ Start Trial | |
| Australia | 2025201108 | ⤷ Start Trial | |
| Brazil | 112017005810 | ⤷ Start Trial | |
| Canada | 2961762 | ⤷ Start Trial | |
| Canada | 3228032 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OPFOLDA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 4273241 | 301330 | Netherlands | ⤷ Start Trial | PRODUCT NAME: CIPAGLUCOSIDASE ALFA; REGISTRATION NO/DATE: EU/1/22/1714 20230324 |
| 3201320 | CA 2024 00012 | Denmark | ⤷ Start Trial | PRODUCT NAME: CIPAGLUCOSIDASE ALFA; REG. NO/DATE: EU/1/22/1714 20230324 |
| 3201320 | LUC00336 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: CIPAGLUCOSIDASE ALFA; AUTHORISATION NUMBER AND DATE: EU/1/22/1714 20230324 |
| 4273241 | PA2025521 | Lithuania | ⤷ Start Trial | PRODUCT NAME: CIPAGLIUKOZIDAZES ALFA; REGISTRATION NO/DATE: EU/1/22/1714 20230320 |
| 3201320 | C20240010 | Finland | ⤷ Start Trial | PRODUCT NAME: ALFATSIPAGLUEKOSIDAAS;REG NO/DATE: EU/1/22/1714 24.03.2023 |
| 4273241 | C20250020 | Finland | ⤷ Start Trial | |
| 3201320 | 2024C/513 | Belgium | ⤷ Start Trial | PRODUCT NAME: CIPAGLUCOSIDASE ALFA; AUTHORISATION NUMBER AND 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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