Epaned is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 9 US drug patents filed from 2017 to 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 25, 2036. Details of Epaned'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). | |||
| US10154987 | Enalapril formulations |
Mar, 2036
(11 years from now) | Active |
| US11040023 | Enalapril formulations |
Mar, 2036
(11 years from now) | Active |
| US9669008 | Enalapril formulations |
Mar, 2036
(11 years from now) | Active |
| US10772868 | Enalapril formulations |
Mar, 2036
(11 years from now) | Active |
| US10039745 | Enalapril formulations |
Mar, 2036
(11 years from now) | Active |
| US10786482 | Enalapril formulations |
Mar, 2036
(11 years from now) | Active |
| US11173141 | Enalapril formulations |
Mar, 2036
(11 years from now) | Active |
| US11141405 | Enalapril formulations |
Mar, 2036
(11 years from now) | Active |
| US9808442 | Enalapril formulations |
Mar, 2036
(11 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 Epaned's patents.
Latest Legal Activities on Epaned's Patents
Given below is the list of recent legal activities going on the following patents of Epaned.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Mar, 2024 | US10786482 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jun, 2022 | US10154987 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Feb, 2022 | US10039745 |
| Patent Issue Date Used in PTA Calculation | 16 Nov, 2021 | US11173141 |
| Recordation of Patent Grant Mailed | 16 Nov, 2021 | US11173141 |
| Email Notification | 30 Oct, 2021 | US11173141 |
| Issue Notification Mailed | 27 Oct, 2021 | US11173141 |
| Mail Response to 312 Amendment (PTO-271) | 20 Oct, 2021 | US11173141 |
| Email Notification | 20 Oct, 2021 | US11173141 |
| Application Is Considered Ready for Issue | 19 Oct, 2021 | US11173141 |
US patents provide insights into the exclusivity only within the United States, but Epaned 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 Epaned's family patents as well as insights into ongoing legal events on those patents.
Epaned's family patents
Coming Soon
Patent Strength Analyzer
YesNo
Thank you for your response 🥳
Generic Launch
Generic Release Date:
Epaned's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 25, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Epaned Generics:
Enalapril Maleate is the generic name for the brand Epaned. 20 different companies have already filed for the generic of Epaned, with Wockhardt Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Epaned's generic
How can I launch a generic of Epaned before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Epaned's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Epaned'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 Epaned -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/mL | 31 Aug, 2018 | 1 | 10 Aug, 2021 | 25 Mar, 2036 | Eligible |
About Epaned
Epaned is a drug owned by Azurity Pharmaceuticals Inc. It is used for managing heart failure and hypertension. Epaned uses Enalapril Maleate as an active ingredient. Epaned was launched by Azurity in 2016.
Market Authorisation Date:
Epaned was approved by FDA for market use on 20 September, 2016.
Active Ingredient:
Epaned uses Enalapril Maleate as the active ingredient. Check out other Drugs and Companies using Enalapril Maleate ingredient
Treatment:
Epaned is used for managing heart failure and hypertension.
Dosage:
Epaned is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG/ML | SOLUTION | Prescription | ORAL |