Eprontia is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2022 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 21, 2040. Details of Eprontia's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11433046 | Compositions and methods for treating epilepsy, seizures and other conditions |
Aug, 2040
(16 years from now) | Active |
| US11911362 | Compositions and methods for treating epilepsy, seizures and other conditions |
Aug, 2040
(16 years from now) | Active |
| US11826343 | Compositions and methods for treating epilepsy, seizures and other conditions |
Aug, 2040
(16 years from now) | Active |
| US11633374 | Compositions and methods for treating epilepsy, seizures and other conditions |
Aug, 2040
(16 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 Eprontia's patents.
Latest Legal Activities on Eprontia's Patents
Given below is the list of recent legal activities going on the following patents of Eprontia.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation | 27 Feb, 2024 | US11911362 |
| Mail Patent eGrant Notification | 27 Feb, 2024 | US11911362 |
| Recordation of Patent Grant Mailed | 27 Feb, 2024 | US11911362 |
| Patent eGrant Notification | 27 Feb, 2024 | US11911362 |
| Recordation of Patent eGrant | 27 Feb, 2024 | US11911362 |
| Email Notification | 27 Feb, 2024 | US11911362 |
| Email Notification | 08 Feb, 2024 | US11911362 |
| Issue Notification Mailed | 07 Feb, 2024 | US11911362 |
| Application Is Considered Ready for Issue | 19 Jan, 2024 | US11911362 |
| Dispatch to FDC | 19 Jan, 2024 | US11911362 |
US patents provide insights into the exclusivity only within the United States, but Eprontia 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 Eprontia's family patents as well as insights into ongoing legal events on those patents.
Eprontia's family patents
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Generic Launch
Generic Release Date:
Eprontia's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 21, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Eprontia Generics:
Topiramate is the generic name for the brand Eprontia. 34 different companies have already filed for the generic of Eprontia, with Glenmark Pharms Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Eprontia's generic
How can I launch a generic of Eprontia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Eprontia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Eprontia's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Eprontia -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg/mL | 06 Oct, 2022 | 1 | 21 Aug, 2040 |
About Eprontia
Eprontia is a drug owned by Azurity Pharmaceuticals Inc. It is used for preventing migraines in patients 12 years and older. Eprontia uses Topiramate as an active ingredient. Eprontia was launched by Azurity in 2021.
Market Authorisation Date:
Eprontia was approved by FDA for market use on 05 November, 2021.
Active Ingredient:
Eprontia uses Topiramate as the active ingredient. Check out other Drugs and Companies using Topiramate ingredient
Treatment:
Eprontia is used for preventing migraines in patients 12 years and older.
Dosage:
Eprontia is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG/ML | SOLUTION | Prescription | ORAL |