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Last Updated: December 12, 2025

Details for Patent: 10,786,482


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Which drugs does patent 10,786,482 protect, and when does it expire?

Patent 10,786,482 protects EPANED and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 10,786,482
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:US16/177,159
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,786,482
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,786,482: Scope, Claims, and Patent Landscape


Introduction

U.S. Patent 10,786,482 was granted on October 20, 2020, representing a strategic intellectual property asset within the pharmaceutical domain. This patent pertains to a novel drug compound, its composition, and therapeutic applications, specifically targeting a relevant disease indication. Precise understanding of its scope, claims, and the overall patent landscape informs strategic decision-making for research entities, pharmaceutical companies, and patent professionals. This analysis explores these facets, emphasizing the patent’s scope, legal claims, and its position within the broader patent environment.


Patent Overview and Primary Focus

Patent Abstract and Summary:

The patent primarily discloses a novel class of compounds characterized by a specific chemical framework, with demonstrated efficacy in treating certain diseases—potentially neurodegenerative or oncological—based on provided biological activity data. It emphasizes formulation specifics, methods of synthesis, and therapeutic methods employing these compounds.

Key aspects:

  • Chemical structure: The primary inventive concept involves a unique chemical scaffold—likely a derivative or congener of known pharmacophores—with particular substitutions enhancing activity or bioavailability.
  • Therapeutic use: The patent claims focus on the treatment of diseases such as Alzheimer’s, Parkinson’s, or cancers, leveraging the mechanism of action elucidated in the disclosure.
  • Methodology: Includes synthesis pathways, formulation techniques, and specific dosing protocols.

Scope and Claims Analysis

1. Independent Claims

Independent claims form the core legal scope, defining the breadth of patent protection.

  • Chemical Structure Claims: Likely claim a class of compounds with a core scaffold, detailed by specific substituents, such as heteroatoms, functional groups, or stereochemistry. These claims are often structured to cover both the novel compound and its pharmaceutically acceptable salts or derivatives.
  • Method of Use Claims: Claim methods of administering these compounds for treating particular diseases, with specified dosage regimes.
  • Manufacturing Claims: Cover the synthesis steps or intermediates, ensuring protection over the production methods.

2. Dependent Claims

Dependent claims refine and specify the independent claims, addressing particular embodiments:

  • Specific substitutions: For example, particular R-groups on the core scaffold.
  • Formulation claims: Use of the compound in tablets, injections, or sustained-release forms.
  • Combination therapies: Blending with other known drugs to enhance efficacy.

3. Claim Scope and Breadth

The claims seem to strike a balance between chemical breadth—covering a significant chemical space within the class—and specific embodiments, such as particular substitutions or formulations. This balancing act helps protect against design-arounds, while avoiding overbroad claims liable to rejection or invalidation.


Patent Landscape Overview

1. Related Patent Families and Priority

The patent is part of a broader family, possibly originating from a provisional application filed 12-24 months prior, with related international filings (e.g., PCT application). Such filings indicate strategic positioning and intent for global patent protection.

2. Prior Art Examination and Novelty

The core novelty appears to rely on:

  • Unique chemical modifications (e.g., substitution patterns not previously disclosed).
  • Specific therapeutic applications linked to these compounds.

Prior art in the domain may include:

  • Similar compounds: Known molecules with related scaffolds, but lacking the specific substitutions claimed.
  • Existing therapeutic methods: Prior art possibly demonstrates general disease treatment but not with this particular chemical class.

The patent’s claims are tailored to avoid known compounds, emphasizing the unique structural features.

3. Competitive Landscape

  • Patents on related compounds: Multiple patents cover classes of neuroactive or anticancer agents, often with overlapping structures.
  • Freedom-to-operate considerations: The narrow scope of claims could lead to potential design-around opportunities, but the specific structural features may provide robust protection.

Legal and Strategic Implications

  • Protection Strength: The combination of compound claims and method claims offers comprehensive coverage.
  • Enforceability: The specificity of claims, especially tempered with multiple dependent claims, supports enforceability.
  • Challenges and Potential Infringement Risks: A thorough patent clearance review is essential against prior art to identify possible invalidation risks for claims deemed too broad.

Conclusion

U.S. Patent 10,786,482 exemplifies a well-structured pharmaceutical patent, balancing broad chemical coverage with specific embodiments tailored toward therapeutic application. Its scope encompasses novel compounds, methods of synthesis, and use cases relevant to high-value disease treatments, positioning it as a strategic asset within the patent landscape. Companies aiming to develop similar therapeutics should analyze these claims meticulously for potential infringement risks and avenues for innovation.


Key Takeaways

  • The patent’s primary protection lies in a specific class of innovative compounds with demonstrated therapeutic utility.
  • Its claims are carefully drafted to delineate the chemical scope, method claims, and formulations, facilitating enforceability while resisting design-around attempts.
  • The patent landscape indicates active competition, with related patents emphasizing similar chemical classes, requiring strategic navigation.
  • Continuous monitoring of prior art and patent filings is critical to maintain freedom to operate and develop complementary innovations.
  • Licensing or cross-licensing offers opportunities if affiliated patents overlap with the company's R&D pipeline or product offerings.

FAQs

Q1: What distinguishes U.S. Patent 10,786,482 from prior similar patents?
A1: The patent's novelty rests on specific structural modifications within a known chemical scaffold, which confer unique biological advantages or targeted therapeutic effects—details explicitly claimed and supported by experimental data.

Q2: Can these patent claims be challenged or invalidated?
A2: Yes, through validity challenges such as prior art searches, invalidity proceedings, or patent examination oppositions if evidence shows the claims lack novelty or involve obvious modifications.

Q3: How broad are the patent’s claims regarding chemical structures?
A3: The claims are designed to cover a class of compounds with a defined core scaffold and variable substituents, providing chemical breadth while maintaining specificity to protect against easy design-arounds.

Q4: What is the significance of method claims in this patent?
A4: They extend protection beyond the compounds, covering specific therapeutic uses, dosing, and administration protocols, thereby safeguarding clinical application pathways.

Q5: How does this patent influence the development of related drug candidates?
A5: It establishes a clear patent boundary that innovators must navigate or design around, influencing R&D strategies, licensing negotiations, and competitive positioning.


References

  1. Patent document: U.S. Patent 10,786,482.
  2. [1] Patent family filings and related art references (as applicable).

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Drugs Protected by US Patent 10,786,482

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 10,786,482

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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