Qbrelis is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 9 US drug patents filed from 2016 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 06, 2035. Details of Qbrelis'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). | |||
| US10406199 | Lisinopril formulations |
Nov, 2035
(11 years from now) | Active |
| US10039800 | Lisinopril formulations |
Nov, 2035
(11 years from now) | Active |
| US9616096 | Lisinopril formulations |
Nov, 2035
(11 years from now) | Active |
| US10265370 | Lisinopril formulations |
Nov, 2035
(11 years from now) | Active |
| US9463183 | Lisinopril formulations |
Nov, 2035
(11 years from now) | Active |
| US11179434 | Lisinopril formulations |
Nov, 2035
(11 years from now) | Active |
| US9814751 | Lisinopril formulations |
Nov, 2035
(11 years from now) | Active |
| US10940177 | Lisinopril formulations |
Nov, 2035
(11 years from now) | Active |
| US11771733 | Lisinopril formulations |
Nov, 2035
(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 Qbrelis's patents.
Latest Legal Activities on Qbrelis's Patents
Given below is the list of recent legal activities going on the following patents of Qbrelis.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Apr, 2024 | US9463183 |
| Patent Issue Date Used in PTA Calculation | 03 Oct, 2023 | US11771733 |
| Mail Patent eGrant Notification | 03 Oct, 2023 | US11771733 |
| Recordation of Patent Grant Mailed | 03 Oct, 2023 | US11771733 |
| Email Notification | 03 Oct, 2023 | US11771733 |
| Recordation of Patent eGrant | 03 Oct, 2023 | US11771733 |
| Patent eGrant Notification | 03 Oct, 2023 | US11771733 |
| Email Notification | 15 Sep, 2023 | US11771733 |
| Issue Notification Mailed | 13 Sep, 2023 | US11771733 |
| Dispatch to FDC | 24 Aug, 2023 | US11771733 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Qbrelis and ongoing litigations to help you estimate the early arrival of Qbrelis generic.
Qbrelis's Litigations
Qbrelis has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 10, 2017, against patent number US9463183. The petitioner KVK-Tech, Inc., challenged the validity or infringement of this patent, with Silvergate Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Qbrelis's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9463183 | July, 2017 | FWD Entered | Silvergate Pharmaceuticals, Inc. | KVK-Tech, Inc. |
US patents provide insights into the exclusivity only within the United States, but Qbrelis 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 Qbrelis's family patents as well as insights into ongoing legal events on those patents.
Qbrelis's family patents
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Generic Launch
Generic Release Date:
Qbrelis's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 06, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Qbrelis Generics:
Lisinopril is the generic name for the brand Qbrelis. 17 different companies have already filed for the generic of Qbrelis, with Prinston Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Qbrelis's generic
How can I launch a generic of Qbrelis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Qbrelis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Qbrelis'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 Qbrelis -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/mL | 24 Oct, 2019 | 1 | 06 Nov, 2035 | Extinguished |
About Qbrelis
Qbrelis is a drug owned by Azurity Pharmaceuticals Inc. It is used for treating acute myocardial infarction, hypertension, and heart failure. Qbrelis uses Lisinopril as an active ingredient. Qbrelis was launched by Azurity in 2016.
Market Authorisation Date:
Qbrelis was approved by FDA for market use on 29 July, 2016.
Active Ingredient:
Qbrelis uses Lisinopril as the active ingredient. Check out other Drugs and Companies using Lisinopril ingredient
Treatment:
Qbrelis is used for treating acute myocardial infarction, hypertension, and heart failure.
Dosage:
Qbrelis 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 |