Qbrelis Patent Expiration

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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10039800 Lisinopril formulations
Nov, 2035

(10 years from now)

Active
US9616096 Lisinopril formulations
Nov, 2035

(10 years from now)

Active
US10265370 Lisinopril formulations
Nov, 2035

(10 years from now)

Active
US9463183 Lisinopril formulations
Nov, 2035

(10 years from now)

Active
US9814751 Lisinopril formulations
Nov, 2035

(10 years from now)

Active
US10940177 Lisinopril formulations
Nov, 2035

(10 years from now)

Active
US11771733 Lisinopril formulations
Nov, 2035

(10 years from now)

Active
US10406199 Lisinopril formulations
Nov, 2035

(10 years from now)

Active
US11179434 Lisinopril formulations
Nov, 2035

(10 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.

Given below is the list of recent legal activities going on the following patents of Qbrelis.

Activity Date Patent Number
Patent litigations
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 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 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.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9463183 July, 2017 FWD Entered
(07 May, 2018)
Silvergate Pharmaceuticals, Inc. KVK-Tech, Inc.

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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

Qbrelis has patent protection in a total of 8 countries. It has a significant patent presence in the US with 57.1% of its patents being US patents. Click below to unlock the full patent family tree for Qbrelis.

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 Generic API suppliers:

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

Alternative Brands for Qbrelis

Qbrelis which is used for treating acute myocardial infarction, hypertension, and heart failure., 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.

Drug Owner Drug Name Treatment Area
Abbvie
Byvalson Used for managing high blood pressure.
Azurity
Bidil Used for treating heart failure.
Katerzia Used for managing hypertension and angina.
Sandoz
Lotrel Used for managing high blood pressure and cardiovascular conditions.





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.

Approval 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