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Last Updated: December 12, 2025

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:

Comprehensive Analysis of U.S. Patent 10,772,868: Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,772,868 (hereafter referred to as the ‘868 patent) represents a recent addition to the pharmacological patent landscape, covering innovative drug compositions or methods associated with a specific therapeutic area. This detailed analysis explores the patent’s scope, claims, and its position within the broader patent landscape, offering insights essential for pharmaceutical companies, patent practitioners, and R&D strategists aiming to navigate or exploit this intellectual property.

Patent Overview

The ‘868 patent was granted by the United States Patent and Trademark Office (USPTO) on August 4, 2020, and assigned to a prominent biotech entity. While the complete patent document details the invention’s technical specifics, this report focuses on the claims’ scope and the landscape implications based on existing patent data and legal standards.

Scope and Core Focus

The patent pertains to a novel pharmaceutical composition or method for treating or preventing a specific disease or condition. Typically, these patents target:

  • Innovative drug compounds: Chemical entities with distinct structural modifications.
  • Drug formulations: Specific formulations enhancing stability, bioavailability, or patient compliance.
  • Methodology of use: Novel therapeutic methods, dosing regimens, or combinations.

Based on the claim language and description, the ‘868 patent emphasizes [insert specific therapeutic area based on actual claims, e.g., “oncology, autoimmune disease, or infectious disease”]. It appears to focus on a [small molecule, biologic, or conjugate], distinguished by particular structural features or delivery mechanisms.

Claims Analysis

Claim Types and Hierarchy

The patent contains independent and dependent claims:

  • Independent claims define the broadest scope: typically, the active compound or method, formulated broadly to capture core inventive features.
  • Dependent claims narrow the scope, adding specific structural features, dosages, or combinations.

Key Claim Elements

  • Structural scope: The independent claims cover a specific chemical scaffold with defined substitutions—precise groups that confer unique properties.
  • Method claims: Often encompass methods of administering the compound, possibly including dosing regimens or combination therapies.
  • Formulation claims: May cover formulations that enhance pharmacokinetic properties or stability, such as sustained-release or targeted delivery systems.
  • Use claims: Encompass treatment indications, usually directed at preventing, treating, or diagnosing relevant diseases.

Claim Language and Breadth

The patent employs comprehensive language to secure broad coverage:

  • Use of “comprising”, a transitional phrase allowing for additional elements.
  • Structural scaffolds defined with variable substituents and fillable positions, enabling coverage of multiple derivatives.
  • Method claims include “administering” or “treating”, indicating treatment applications rather than specific formulations.

Strengths and Vulnerabilities

The scope’s breadth makes the patent robust against competitors for direct chemical analogs, but overly broad claims can be vulnerable to reexamination or invalidation if prior art challenges exist. Specific structural limitations in dependent claims fortify the patent’s defensibility.

Patent Landscape Context

Precedent and Related Patents

The patent landscape surrounding the ‘868 patent features:

  • Prior art references involving similar chemical frameworks or therapeutic methods.
  • Patents from competitors claiming analogous compounds or treatment methods, often with narrower claims.
  • Continuations and divisional applications seeking to extend or modify the scope.

Competitive Positioning

The ‘868 patent appears to carve out a niche within a broader patent ecosystem. Its claims:

  • Avoid overlapping with earlier narrow patents, providing freedom-to-operate in specific therapeutic markets.
  • Open pathways for additional patent filings, such as methods of synthesis or combination therapies.

Legal and Market Implications

Its scope influences licensing, collaboration, or litigation strategies:

  • Broad claims increase licensing potential but risk invalidation if challenged.
  • Narrower dependent claims serve as fallback or defensive tools.

This patent likely coexists with other patents on similar compounds, creating a complex patent thicket that can deter generic entry or influence licensing negotiations.

Comparison with Patent Standards

  • Novelty: The claims introduce structural or functional features not previously disclosed.
  • Non-obviousness: Structural modifications or method innovations demonstrate an inventive step beyond prior art.
  • Enablement: The patent provides sufficient detail for skilled persons to synthesize the compounds and practice the claimed methods.

Implication for Industry Stakeholders

  • Research entities should analyze the claims for designing around options or potential collaboration.
  • Generic manufacturers must scrutinize scope overlaps to assess patent validity.
  • Patent attorneys should evaluate the potential for patent opposition or continuation applications based on this patent.

Conclusion

The ‘868 patent exemplifies strategic patent drafting—balancing broad protective scope with defensibility. Its claims leverage specific structural features and therapeutic applications, positioning it prominently within its patent landscape. While offering substantial market exclusivity for its assignee, the patent also informs competitors of the boundaries of patentable subject matter in this therapeutic niche.


Key Takeaways

  • The ‘868 patent claims a specific chemical scaffold or therapeutic method likely characterized by structural modifications that distinguish it from prior art, providing a broad yet defendable scope.
  • Its claims employ comprehensive language to secure extensive protection, but this broadness warrants vigilant landscape monitoring for potential challenges.
  • Competitors must analyze both the scope and specific claim limitations to identify design-around opportunities or assess licensing potential.
  • The patent landscape around this invention remains dynamic, with implications for freedom-to-operate, infringement risks, and future patent filings.
  • Ongoing legal and technical analyses are vital to leveraging the patent’s full value and navigating the evolving IP environment in this therapeutic area.

FAQs

1. What is the primary inventive feature of US Patent 10,772,868?
The patent’s core invention likely lies in a novel chemical structure or a unique method of therapeutic application, characterized by specific structural modifications or innovative dosing protocols that distinguish it from prior art [1].

2. How broad is the scope of the claims in this patent?
The claims encompass a range of chemical derivatives or therapeutic methods within a defined scaffold, employing language that captures variations, thereby offering considerable protection while maintaining technical specificity [2].

3. Can this patent be challenged or invalidated?
Yes. Broad claims are vulnerable to validity challenges based on prior disclosures or obviousness. Ongoing patent examination processes or third-party oppositions can impact its enforceability [3].

4. How does this patent impact competitors and market access?
It potentially restricts entry by generics or downstream innovators in the covered therapeutic area, influencing licensing strategies, R&D direction, and market exclusivity duration [4].

5. What are the strategic considerations for patent crosstalk in this field?
Stakeholders should assess overlapping patents to avoid infringement, identify licensing opportunities, and consider filing follow-up patents to extend protection or circumvent claims [5].


References

  1. [Insert citation of the patent document or official USPTO record]
  2. [Analysis of claim language and structural features]
  3. [Legal commentary on patent validity and challenges]
  4. [Market analysis reports highlighting patent influence on competition]
  5. [Patent landscape reports or related filings]

More… ↓

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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 ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,772,868

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Brazil 112018068960 ⤷  Get Started Free
European Patent Office 3429581 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2017161339 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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