Opfolda is a drug owned by Amicus Therapeutics Us Llc. It is protected by 7 US drug patents filed in 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 12, 2037. Details of Opfolda's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US10208299 | Highly potent acid alpha-glucosidase with enhanced carbohydrates |
Sep, 2035
(11 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11278599 | High concentration alpha-glucosidase compositions for the treatment of Pompe disease |
Mar, 2033
(8 years from now) | Active |
| US10512677 | High concentration alpha-glucosidase compositions for the treatment of pompe disease |
Mar, 2033
(8 years from now) | Active |
| US10961522 | Highly potent acid alpha-glucosidase with enhanced carbohydrates |
Sep, 2035
(11 years from now) | Active |
| US11753632 | Highly potent acid alpha-glucosidase with enhanced carbohydrates |
Sep, 2035
(11 years from now) | Active |
| US11278601 | Augmented acid alpha-glucosidase for the treatment of Pompe disease |
Dec, 2036
(12 years from now) | Active |
| US10857212 | Augmented acid alpha-glucosidase for the treatment of Pompe disease |
Aug, 2037
(13 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Opfolda's patents.
Latest Legal Activities on Opfolda's Patents
Given below is the list of recent legal activities going on the following patents of Opfolda.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 May, 2024 | US10857212 |
| Letter from FDA or Dept of Agriculture re PTE application | 08 May, 2024 | US10208299 |
| Initial letter Re: PTE Application to regulating agency | 02 Feb, 2024 | US10208299 |
| Patent Term Extension Application under 35 USC 156 Filed | 21 Nov, 2023 | US10208299 |
| Email Notification | 12 Sep, 2023 | US11753632 |
| Patent eGrant Notification | 12 Sep, 2023 | US11753632 |
| Mail Patent eGrant Notification | 12 Sep, 2023 | US11753632 |
| Patent Issue Date Used in PTA Calculation | 12 Sep, 2023 | US11753632 |
| Recordation of Patent eGrant | 12 Sep, 2023 | US11753632 |
| Recordation of Patent Grant Mailed | 12 Sep, 2023 | US11753632 |
FDA has granted several exclusivities to Opfolda. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Opfolda, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Opfolda.
Exclusivity Information
Opfolda holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Opfolda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 28, 2026 |
US patents provide insights into the exclusivity only within the United States, but Opfolda is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Opfolda's family patents as well as insights into ongoing legal events on those patents.
Opfolda's family patents
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Generic Launch
Generic Release Date:
Opfolda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 12, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Opfolda Generics:
Miglustat is the generic name for the brand Opfolda. 3 different companies have already filed for the generic of Opfolda, with Ani Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Opfolda's generic
About Opfolda
Opfolda is a drug owned by Amicus Therapeutics Us Llc. It is used for managing symptoms of Pompe disease. Opfolda uses Miglustat as an active ingredient. Opfolda was launched by Amicus Therap Us in 2023.
Market Authorisation Date:
Opfolda was approved by FDA for market use on 28 September, 2023.
Active Ingredient:
Opfolda uses Miglustat as the active ingredient. Check out other Drugs and Companies using Miglustat ingredient
Treatment:
Opfolda is used for managing symptoms of Pompe disease.
Dosage:
Opfolda is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 65MG | CAPSULE | Prescription | ORAL |