Katerzia Patent Expiration

Katerzia is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 10 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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11918685 Amlodipine formulations
Oct, 2037

(13 years from now)

Active
US10894039 Amlodipine formulations
Oct, 2037

(13 years from now)

Active
US11471409 Amlodipine formulations
Oct, 2037

(13 years from now)

Active
US10959991 Amlodipine formulations
Oct, 2037

(13 years from now)

Active
US11701326 Amlodipine formulations
Oct, 2037

(13 years from now)

Active
US11484498 Amlodipine formulations
Oct, 2037

(13 years from now)

Active
US10952998 Amlodipine formulations
Oct, 2037

(13 years from now)

Active
US11364230 Amlodipine formulations
Oct, 2037

(13 years from now)

Active
US10695329 Amlodipine formulations
Oct, 2037

(13 years from now)

Active
US10799453 Amlodipine formulations
Apr, 2039

(14 years from now)

Active

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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

Katerzia has patent protection in a total of 6 countries. It has a significant patent presence in the US with 63.6% of its patents being US patents. Click below to unlock the full patent family tree for Katerzia.

Family Patents

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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 Generics:

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




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.

Market Authorisation 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