Katerzia is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 11 US drug patents filed from 2020 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 11, 2039. Details of Katerzia'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). | |||
| US10799453 | Amlodipine formulations |
Apr, 2039
(13 years from now) | Active |
| US10695329 | Amlodipine formulations |
Oct, 2037
(12 years from now) | Active |
| US11701326 | Amlodipine formulations |
Oct, 2037
(12 years from now) | Active |
| US11484498 | Amlodipine formulations |
Oct, 2037
(12 years from now) | Active |
| US10952998 | Amlodipine formulations |
Oct, 2037
(12 years from now) | Active |
| US11364230 | Amlodipine formulations |
Oct, 2037
(12 years from now) | Active |
| US10959991 | Amlodipine formulations |
Oct, 2037
(12 years from now) | Active |
| US10894039 | Amlodipine formulations |
Oct, 2037
(12 years from now) | Active |
| US11471409 | Amlodipine formulations |
Oct, 2037
(12 years from now) | Active |
| US12053461 | Amlodipine formulations |
Oct, 2037
(12 years from now) | Active |
| US11918685 | Amlodipine formulations |
Oct, 2037
(12 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 Katerzia's patents.
Latest Legal Activities on Katerzia's Patents
Given below is the list of recent legal activities going on the following patents of Katerzia.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Apr, 2024 | US10799453 |
| Patent Issue Date Used in PTA Calculation Critical | 05 Mar, 2024 | US11918685 |
| Recordation of Patent eGrant | 05 Mar, 2024 | US11918685 |
| Patent eGrant Notification | 05 Mar, 2024 | US11918685 |
| Mail Patent eGrant Notification | 05 Mar, 2024 | US11918685 |
| Recordation of Patent Grant Mailed Critical | 05 Mar, 2024 | US11918685 |
| Email Notification Critical | 05 Mar, 2024 | US11918685 |
| Email Notification Critical | 15 Feb, 2024 | US11918685 |
| Issue Notification Mailed Critical | 14 Feb, 2024 | US11918685 |
| Dispatch to FDC | 30 Jan, 2024 | US11918685 |
US patents provide insights into the exclusivity only within the United States, but Katerzia 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 Katerzia's family patents as well as insights into ongoing legal events on those patents.
Katerzia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Katerzia's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 11, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Katerzia Generic API suppliers:
Amlodipine Benzoate is the generic name for the brand Katerzia. 1 company has already filed for the generic of Katerzia. Check out the entire list of companies who have already received approval for Katerzia's generic
How can I launch a generic of Katerzia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Katerzia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Katerzia'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 Katerzia -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/mL | 29 Dec, 2020 | 1 | 13 Jun, 2023 | 11 Apr, 2039 | Eligible |
Alternative Brands for Katerzia
Katerzia which is used for managing hypertension and angina., has several other brand drugs in the same treatment category . 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.
About Katerzia
Katerzia is a drug owned by Azurity Pharmaceuticals Inc. It is used for managing hypertension and angina. Katerzia uses Amlodipine Benzoate as an active ingredient. Katerzia was launched by Azurity in 2019.
Approval Date:
Katerzia was approved by FDA for market use on 08 July, 2019.
Active Ingredient:
Katerzia uses Amlodipine Benzoate as the active ingredient. Check out other Drugs and Companies using Amlodipine Benzoate ingredient
Treatment:
Katerzia is used for managing hypertension and angina.
Dosage:
Katerzia is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1MG BASE/ML | SUSPENSION | Prescription | ORAL |