Epaned Kit is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2013 to 2018 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 06, 2032. Details of Epaned Kit'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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9968553 | Enalapril compositions |
Nov, 2032
(8 years from now) | Active |
| US8778366 | Enalapril compositions |
Nov, 2032
(8 years from now) | Active |
| US8568747 | Enalapril compositions |
Nov, 2032
(8 years from now) | Active |
| US9855214 | Enalapril compositions |
Nov, 2032
(8 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 Kit's patents.
Latest Legal Activities on Epaned Kit's Patents
Given below is the list of recent legal activities going on the following patents of Epaned Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Nov, 2021 | US9968553 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Jul, 2021 | US9855214 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Apr, 2021 | US8568747 |
| Patent Issue Date Used in PTA Calculation Critical | 15 May, 2018 | US9968553 |
| Recordation of Patent Grant Mailed Critical | 15 May, 2018 | US9968553 |
| Email Notification Critical | 04 May, 2018 | US9968553 |
| Application ready for PDX access by participating foreign offices Critical | 03 May, 2018 | US9968553 |
| PG-Pub Issue Notification Critical | 03 May, 2018 | US9968553 |
| Email Notification Critical | 26 Apr, 2018 | US9968553 |
| Issue Notification Mailed Critical | 25 Apr, 2018 | US9968553 |
US patents provide insights into the exclusivity only within the United States, but Epaned Kit 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 Kit's family patents as well as insights into ongoing legal events on those patents.
Epaned Kit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Epaned Kit's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 06, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Epaned Kit Generic API suppliers:
Enalapril Maleate is the generic name for the brand Epaned Kit. 21 different companies have already filed for the generic of Epaned Kit, with Wockhardt Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Epaned Kit's generic
How can I launch a generic of Epaned Kit before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Epaned Kit's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Epaned Kit'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 Kit -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/mL | 21 Jun, 2016 | 1 | 06 Nov, 2032 |
Alternative Brands for Epaned Kit
Epaned Kit which is used for treating left ventricular dysfunction and heart failure., has several other brand drugs in the same treatment category and using the same active ingredient (Enalapril Maleate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Azurity |
| |||
| Novartis Pharms Corp |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Enalapril Maleate, Epaned Kit's active ingredient. Check the complete list of approved generic manufacturers for Epaned Kit
About Epaned Kit
Epaned Kit is a drug owned by Azurity Pharmaceuticals Inc. It is used for treating left ventricular dysfunction and heart failure. Epaned Kit uses Enalapril Maleate as an active ingredient. Epaned Kit was launched by Azurity in 2013.
Approval Date:
Epaned Kit was approved by FDA for market use on 13 August, 2013.
Active Ingredient:
Epaned Kit uses Enalapril Maleate as the active ingredient. Check out other Drugs and Companies using Enalapril Maleate ingredient
Treatment:
Epaned Kit is used for treating left ventricular dysfunction and heart failure.
Dosage:
Epaned Kit is available in for solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | Discontinued | ORAL |