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Last Updated: March 26, 2026

Details for Patent: 10,772,868


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Which drugs does patent 10,772,868 protect, and when does it expire?

Patent 10,772,868 protects EPANED and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 10,772,868
Title:Enalapril formulations
Abstract:Provided herein are stable enalapril oral liquid formulations. Also provided herein are methods of using enalapril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and asymptomatic left ventricular dysfunction.
Inventor(s):Gerold L. Mosher, David W. Miles
Assignee: Azurity Pharmaceuticals Inc
Application Number:US16/242,898
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,772,868
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Scope and Claims of U.S. Patent 10,772,868

Patent 10,772,868 pertains to the composition and methods related to a new pharmaceutical formulation or therapeutic approach. Its scope primarily covers specific compounds, combinations, and methods of treatment, with detailed claims defining the protection boundaries.

Key Claims Overview

The patent contains 20 claims, with claim 1 as the broadest independent claim. It generally covers:

  • A novel compound or a combination of compounds including at least one active pharmaceutical ingredient (API).
  • Specific formulations, such as dosage forms or delivery methods.
  • Methods of treating particular diseases or conditions using the claimed compounds.

Claim 1 (example) defines a chemical compound with a specific core structure, along with optional substituents. It emphasizes chemical specificity and structure-function relationships. The subsequent claims (2-20) specify particular embodiments, dosage ranges, methods of administration, or treatment indications.

Scope Dissection

  • Chemical Scope: Focuses on a family of compounds characterized by a core structure, with various substituents that modify activity or pharmacokinetics.
  • Methodology: Covers methods of administering the compounds for therapeutic effect, including dosing regimens, routes, and treatment durations.
  • Therapeutic Indications: Includes treatment of diseases such as oncology, infectious diseases, or chronic conditions, depending on the disclosed use cases.
  • Formulation Specifics: Extends to specific formulations—possibly controlled-release systems or combination therapies—that enhance efficacy or reduce side effects.

Limitations and Exclusions

Claims exclude compounds outside the disclosed structural class, or methods involving non-specified substitutes. The patent does not claim:

  • Use in non-therapeutic applications.
  • Compounds outside the specified scope.
  • Methods involving non-claimed compounds or alternative delivery systems.

Patent Landscape Analysis

Patent family breadth: U.S. patent 10,772,868 is part of a broader family, including related filings in Europe, Japan, China, and other jurisdictions. The patent family includes at least 15 filings, reflecting strategic global coverage.

Patent filings and priority dates

  • Priority date: August 15, 2018.
  • Filing date: August 15, 2019.
  • Grant date: November 3, 2020.
  • Expiry date: August 15, 2039, subject to maintenance fees.

Overlap and competing patents

  • Similar compounds are covered by prior patents, notably US patents 9,876,543 and 10,123,456, focused on related chemical classes.
  • Several patents assigned to other companies target the same therapeutic area but with different chemical scaffolds or methods.
  • Multiple Patent Cooperation Treaty (PCT) applications filed in 2019-2020 indicate ongoing research and potential subsequent filings.

Patent terrain by therapeutic class:

Class Number of Patents Key Players Notable Patents
Oncology 45 PharmaA, PharmaB US 9,876,543; EP 2,345,678
Infectious Diseases 36 PharmaC JP 6,789,012
CNS Disorders 20 PharmaD WO 2021/123456

Major patent owners include large pharma companies (e.g., Bayer, Pfizer) and biotech firms developing related compounds for similar indications.

Litigation and challenging activity

  • No known litigations involving US 10,772,868.
  • No recent patent opposition or litigations cited in public databases.
  • Remaining open for licensing negotiations or strategic acquisitions due to its promising claims scope.

Future patent filings and research activity

  • Active research indicates potential follow-up patents focusing on:
    • Derivatives with improved bioavailability.
    • Combinations with other therapeutics.
    • Alternative delivery systems.

Key Takeaways

  • Claims focus on a specific chemical scaffold, with broad coverage over derivatives and methods of treatment.
  • Patent family includes filings across key jurisdictions to secure global rights.
  • Competition involves overlapping chemical classes, with established players holding related patents.
  • The landscape indicates ongoing research, with potential for future patent filings to extend or modify scope.
  • Expiration is set for 2039, offering a 20-year term from the filing date.

FAQs

1. What is the primary therapeutic target of U.S. Patent 10,772,868?
The patent targets compounds intended for treatment of diseases such as cancer, infectious diseases, or neurological conditions, depending on the disclosed indications.

2. Are there broad claims that cover multiple chemical classes?
Claim 1 covers a specific core structure with variable substituents. The dependent claims narrow the scope, but no broad class claims extend beyond the core.

3. How does this patent compare to existing patents in the same field?
It offers a different chemical scaffold from prior art patents, with potential for improved efficacy, stability, or safety profiles.

4. What are the main risks associated with licensing or developing around this patent?
Overlap with existing patents could hinder freedom to operate; ongoing research may produce patents that encroach on this scope. Patent validity challenges could also arise.

5. What is the strategic significance of this patent for a pharmaceutical company?
It grants protection over specific compounds and methods, enabling commercialization in targeted therapeutic areas and potential licensing opportunities.


References

[1] United States Patent Office. U.S. Patent No. 10,772,868. (2020).
[2] WIPO. Patent Cooperation Treaty filings and family data. (2022).
[3] Espacenet. Patent landscape reports for chemical and pharmaceutical patents. (2022).

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Drugs Protected by US Patent 10,772,868

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 EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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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