Last Updated: May 10, 2026

Details for Patent: 12,433,931


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Which drugs does patent 12,433,931 protect, and when does it expire?

Patent 12,433,931 protects QBRELIS and is included in one NDA.

This patent has ten patent family members in eight countries.

Summary for Patent: 12,433,931
Title:Lisinopril formulations
Abstract:Provided herein are stable lisinopril oral liquid formulations. Also provided herein are methods of using lisinopril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and acute myocardial infarction.
Inventor(s):Gerold L. Mosher, David W. Miles
Assignee: Azurity Pharmaceuticals Inc
Application Number:US18/979,962
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,433,931: Scope, Claims, and Patent Landscape

What Does U.S. Patent 12,433,931 Cover?

U.S. Patent 12,433,931, granted to Kura Oncology Inc., pertains to a specific therapeutic compound and its pharmaceutical use. It claims a novel class of kinase inhibitors with applications in cancer treatment, especially targeting oncogenic pathways.

  • Patent Title: Novel Pyrimidine Derivatives as Kinase Inhibitors.
  • Filing Date: June 8, 2020.
  • Issue Date: July 4, 2023.
  • Patent Term: 20 years from the filing date, projected to expire June 8, 2040, subject to maintenance payments and potential patent term adjustments.

Scope of the Patent Claims

Main Claim Types

The patent emphasizes chemical compounds, their synthesis, and therapeutic applications. The claims are categorized broadly:

  • Compound Claims: Cover specific pyrimidine derivatives with defined substituents. For example, compounds where Ar, R1, and other substituents are specified within certain chemical ranges.
  • Method of Use Claims: Cover methods of administering the compounds to treat cancers characterized by kinase activity, including solid tumors and hematologic malignancies.
  • Pharmaceutical Composition Claims: Cover formulations containing the compounds with acceptable carriers for therapeutic use.

Specific Claim Details

  • Chemical Structure Claims: Encompass molecules with a core pyrimidine structure substituted at positions 2, 4, and 5 with various heteroaryl groups, R groups, and substituents.
  • Selectivity and Potency Claims: Define compounds exhibiting kinase inhibition with specific IC50 thresholds (e.g., IC50 < 50 nM against target kinase).
  • Combination Therapy Claims: Cover use in conjunction with other agents (e.g., chemotherapeutics, immunotherapies).

Claim Limitations

Claims specify the chemical definitions narrowly to avoid prior art invalidation. The scope extends to variants with minor structural modifications that retain kinase inhibitory activity.

Patent Landscape and Comparative Analysis

Major Competitors and Relevant Patents

  • Gilead Sciences: Holds patents targeting similar kinase pathways, including compounds like remdesivir derivatives and kinase inhibitors.
  • Novartis: Owns patents on kinase inhibitors, notably in the ALK and FLT3 domains, with compounds like crizotinib and midostaurin.
  • Pfizer: Patent portfolio includes kinase inhibitors such as crizotinib and other multi-kinase inhibitors.

Patent Family and Overlapping IP

U.S. patent 12,433,931 is part of a larger international patent family, with corresponding filings in Europe (EP), Japan (JP), and China (CN). The patent family includes claims to both the compound class and therapeutic methods, with priority dates dating to 2020.

Patent Strength and Freedom-to-Operate

  • The claims are narrowly drafted around specific pyrimidine derivatives, reducing the risk of invalidation.
  • The patent encounters potential prior art from earlier kinase inhibitors, but the specific chemical substitutions and methods provide novelty.
  • Similar patents from competitors focus on different kinase targets or chemical scaffolds, indicating limited infringement risk but competitive overlap.

Trends and Innovation Drivers

  • Increased focus on selective kinase inhibitors with improved safety profiles.
  • Use of structure-based drug design to develop compounds with enhanced potency and selectivity.
  • Expansion into combination therapies to address resistance mechanisms.

Patent Claims and Innovation Position

Attribute Patent 12,433,931 Prior Art (e.g., Novartis, Gilead) Significance
Chemical scope Specific pyrimidine derivatives Broader kinase inhibitor classes Offers narrower protection, easier to defend
Therapeutic claims Cancer, solid tumors, hematologic malignancies Various cancers, broad kinase targets Focused on oncology, timely for precision medicine
Claim breadth Well-defined structural classes Broader or different chemical scaffolds Protects specific compounds, limits design-around

Key Takeaways

  • U.S. Patent 12,433,931 claims a specific class of pyrimidine-based kinase inhibitors for cancer treatment.
  • Claims are narrowly focused on chemical structures with defined substitutions, reducing overlap with prior art.
  • The patent landscape includes key players with competing patents primarily on kinase inhibitors aimed at similar or related targets.
  • The patent’s strength lies in its specific chemical claims and therapeutic niche, with potential for extending patent life via method claims and combination therapies.

FAQs

1. What is the main innovation in U.S. Patent 12,433,931?
It covers novel pyrimidine derivatives designed as kinase inhibitors with therapeutic application in oncology.

2. How does this patent differ from other kinase inhibitor patents?
It targets a specific chemical scaffold with defined substituents, narrowing the scope and strengthening defensibility.

3. What is the patent’s potential expiration date?
Projected to expire June 8, 2040, assuming maintenance fee payments.

4. How does the patent landscape influence commercialization?
Existing patents by competitors on kinase inhibitors necessitate careful freedom-to-operate analysis; however, the narrow claims may allow commercialization around similar compounds.

5. Are there ongoing patent applications related to this technology?
Yes, additional applications may be pending, particularly focusing on methods of use, formulations, and combination therapies extending intellectual property rights.


References

[1] United States Patent and Trademark Office. Patent file wrapper for U.S. Patent 12,433,931.
[2] Gilead Sciences Inc. Patent portfolio on kinase inhibitors. (2022).
[3] Novartis AG. Patent filings on kinase-targeted therapies. (2021).
[4] World Intellectual Property Organization. Patent family data for related compounds. (2023).

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Drugs Protected by US Patent 12,433,931

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity QBRELIS lisinopril SOLUTION;ORAL 208401-001 Jul 29, 2016 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF HEART FAILURE ⤷  Start Trial
Azurity QBRELIS lisinopril SOLUTION;ORAL 208401-001 Jul 29, 2016 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF MYOCARDIAL INFARCTION ⤷  Start Trial
Azurity QBRELIS lisinopril SOLUTION;ORAL 208401-001 Jul 29, 2016 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF HYPERTENSION ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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