Edarbi is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2013 to 2015. Out of these, 3 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 26, 2028. Details of Edarbi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US7157584 | Benzimidazole derivative and use thereof |
May, 2025
(9 months from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5583141 | Heterocyclic compounds and their use as angiotensin antagonists |
Dec, 2013
(10 years ago) |
Expired
|
| US5958961 | Pharmaceutical composition for angiotensin II-mediated diseases |
Jun, 2014
(10 years ago) |
Expired
|
| US7572920 | Benzimidazole derivative and use as a II receptor antagonist |
Jan, 2025
(5 months from now) | Active |
| US9066936 | Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent |
Mar, 2028
(3 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 Edarbi's patents.
Latest Legal Activities on Edarbi's Patents
Given below is the list of recent legal activities going on the following patents of Edarbi.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Nov, 2022 | US9066936 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Sep, 2020 | US7572920 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Dec, 2018 | US9066936 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Jun, 2018 | US7157584 |
| Mail O.P. Petition Decision | 14 Jun, 2016 | US9066936 |
| Email Notification | 14 Jun, 2016 | US9066936 |
| Mail-Petition Decision - Dismissed | 10 Jun, 2016 | US9066936 |
| Adjustment of PTA Calculation by PTO | 09 Jun, 2016 | US9066936 |
| Petition Decision - Dismissed | 09 Jun, 2016 | US9066936 |
| O.P. Petition Decision | 09 Jun, 2016 | US9066936 |
FDA has granted several exclusivities to Edarbi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Edarbi, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Edarbi.
Exclusivity Information
Edarbi holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Edarbi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 25, 2016 |
US patents provide insights into the exclusivity only within the United States, but Edarbi 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 Edarbi's family patents as well as insights into ongoing legal events on those patents.
Edarbi's family patents
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Generic Launch
Generic Release Date:
Edarbi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 26, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Edarbi Generics:
Azilsartan Kamedoxomil is the generic name for the brand Edarbi. 1 company has already filed for the generic of Edarbi. Check out the entire list of companies who have already received approval for Edarbi's generic
How can I launch a generic of Edarbi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Edarbi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Edarbi'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 Edarbi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg and 80 mg | 10 Apr, 2020 | 1 | 20 Jul, 2022 | 26 Mar, 2028 | Eligible |
About Edarbi
Edarbi is a drug owned by Azurity Pharmaceuticals Inc. It is used for lowering blood pressure. Edarbi uses Azilsartan Kamedoxomil as an active ingredient. Edarbi was launched by Azurity in 2011.
Market Authorisation Date:
Edarbi was approved by FDA for market use on 25 February, 2011.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Edarbi is 25 February, 2011, its NCE-1 date is estimated to be 25 February, 2015
Active Ingredient:
Edarbi uses Azilsartan Kamedoxomil as the active ingredient. Check out other Drugs and Companies using Azilsartan Kamedoxomil ingredient
Treatment:
Edarbi is used for lowering blood pressure.
Dosage:
Edarbi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG MEDOXOMIL | TABLET | Prescription | ORAL |
| EQ 80MG MEDOXOMIL | TABLET | Prescription | ORAL |