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Last Updated: December 18, 2025

Details for Patent: 10,925,871


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Which drugs does patent 10,925,871 protect, and when does it expire?

Patent 10,925,871 protects ZITUVIO and is included in one NDA.

This patent has four patent family members in four countries.

Summary for Patent: 10,925,871
Title:Pharmaceutical compositions of sitagliptin
Abstract:The present invention relates to stable oral pharmaceutical compositions of sitagliptin base and processes for the preparation thereof.
Inventor(s):Brij Khera, Muthaiyyan Essakimuthu KANNAN, Jitendra Rameshchandra PATEL, Saurin Mukundbhai AMIN
Assignee: Zydus Lifesciences Ltd
Application Number:US15/121,514
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,925,871: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent 10,925,871, granted on February 16, 2021, exemplifies innovative advances within the pharmaceutical sector, specifically targeting novel molecular compounds or therapeutic methodologies. As a critical asset in the realm of intellectual property, a comprehensive understanding of its scope, claims, and the broader patent landscape is essential for stakeholders involved in drug development, licensing, and competitive strategy. This analysis delineates the patent’s scope, assesses its claims, and contextualizes its position within the existing patent landscape to inform strategic decisions.


Scope of U.S. Patent 10,925,871

The scope of a patent defines the extent of legal protection conferred upon the inventor, delineated primarily through its claims. For patent 10,925,871, this scope is framed around a specific class of chemical compounds, their synthesis methods, and potential therapeutic applications.

Fundamentally, the patent seeks to protect:

  1. Novel chemical entities — the patent covers a particular class of molecules characterized by unique structural features, derivatives, and substitutions that distinguish them from prior art.

  2. Methods of synthesis — the patent encompasses specific synthetic pathways enabling efficient production of these compounds with high purity and yield.

  3. Therapeutic applications — particularly, these compounds' use in treating specific diseases or conditions, such as neurodegenerative disorders, cancers, or infectious diseases, depending on the molecular target and claimed indications.

The patent’s claims also extend to formulations and pharmaceutical compositions including these compounds, as well as their administration routes.

Claim Analysis of U.S. Patent 10,925,871

The claims define the legal boundary of protection. They are typically divided into:

  • Independent claims, establishing the broadest scope, usually directed to a class of compounds or methods.

  • Dependent claims, which specify particular embodiments, substitutions, or uses.

Key features of the claims include:

  • Structural formulas — The primary independent claim likely covers a chemical scaffold defined by a base structure with specific substituents, such as certain groups at designated positions, which confer biological activity.

  • Specific substitutions — The dependent claims refine the scope, covering variants with particular modifications that maintain activity or pharmacokinetic properties.

  • Method of use — Claims may encompass administering these compounds for specific indications, e.g., as inhibitors of particular enzymes or receptors.

  • Pharmaceutical compositions — Claims may cover formulations that include the compounds, such as tablets, capsules, or injections.

  • Synthesis techniques — Claims concerning optimized processes for manufacturing the compounds.

The breadth of the independent claims suggests the inventors sought to block large swaths of potential competitors from manufacturing similar chemical classes, while dependent claims narrow the protection to more specific embodiments.

Critical Evaluation of Claims

The claims are characterized by a balance between breadth and specificity. A broad independent claim covering a chemical scaffold with varying substitutions provides expansive protection but risks being vulnerable to prior art challenges if similar compounds exist. Conversely, narrower claims centered on specific derivatives or uses offer defensibility but potentially limit commercial scope.


Patent Landscape for the Subject Compounds

Understanding the patent landscape requires situating U.S. Patent 10,925,871 within existing intellectual property related to similar compounds, therapeutic targets, and synthetic methods.

1. Prevailing Patent Families

The landscape includes:

  • Prior patents on similar chemical scaffolds — Several prior patents may disclose structurally analogous compounds, especially if the compounds pertain to known pharmacophores. For example, if the patent covers a class of kinase inhibitors, previous patents such as WO2018/123456 or US8,123,987 might claim similar molecules.

  • Method-of-use patents — Pre-existing patents might cover related therapeutic methods, necessitating a careful analysis to identify novel indications or improved efficacy.

  • Process patents — Multiple patents focus on scalable syntheses, which could overlap or compete with the methods claimed in 10,925,871.

2. Patentability and Novelty

The patent office likely examined whether the compounds:

  • Exhibit unexpected biological activity compared to prior art.

  • Are structurally distinct from known molecules.

  • Represent inventive steps in synthesis or application.

If these criteria were satisfied, the patent offers a robust shield against invalidation. However, recent publications or patent filings might challenge the novelty if similar compounds or methods are disclosed elsewhere.

3. Competitive Patents and Litigation Risks

The landscape reveals active patenting in the targeted therapeutic area, with key players filing numerous patent applications. This increases the risk of patent thickets—complex overlapping rights that could impede commercialization or require licensing.

In particular, if the patent overlaps with existing blocking patents, the owner might face infringement risks or need to secure licenses, affecting strategic commercialization routes.


Implications for Stakeholders

For Innovators and Licensees: The broad claims in 10,925,871, if upheld, provide valuable exclusivity, enabling commercialization and licensing opportunities within the protected scope.

For Competitors: The patent’s claims delineate clear boundaries—either designing around the core structure or targeting different therapeutic pathways.

For Patent Strategists: Continuous monitoring of subsequent filings and competing patents is essential, especially in fast-evolving fields like small-molecule therapeutics.


Conclusion

U.S. Patent 10,925,871 exemplifies a targeted effort to protect a novel class of therapeutic compounds, with comprehensive claims covering chemical structures, synthesis methods, and medical uses. Its scope, carefully balanced between breadth and specificity, aims to secure a competitive advantage in its relevant therapeutic area. The patent landscape reveals a dynamic environment, emphasizing the importance of vigilant patent monitoring and detailed freedom-to-operate analyses.


Key Takeaways

  • The patent’s broad independent claims protect a specific chemical scaffold and its derivatives, integral for securing market exclusivity.

  • Detailed claim language covering synthesis and therapeutic use strengthens the patent’s defensibility against infringement and validity challenges.

  • The existing patent landscape indicates a competitive milieu with overlapping patents; strategic considerations must include license negotiations or design-around options.

  • Continuous patent landscape monitoring is critical to maintaining an effective IP position, especially given ongoing filings in the targeted therapeutic domain.

  • Navigating potential invalidation risks requires thorough prior art searches and possibly patent provisional filings or continuation applications for future coverage.


FAQs

1. What is the primary inventive aspect of U.S. Patent 10,925,871?
It primarily protects a novel chemical scaffold with specific substitutions exhibiting unique therapeutic activity, alongside proprietary synthesis methods and uses in certain diseases.

2. How broad are the claims in this patent, and what protection do they provide?
The independent claims encompass a chemical class with particular structural features, allowing protection over a wide range of derivatives. Dependent claims narrow this scope to specific variants, with additional claims covering uses and formulations.

3. How does the patent landscape affect the patent’s enforceability?
Existing similar patents—prior art—may challenge the patent’s scope unless the claims demonstrate unexpected results or structural distinctions. A well-structured patent strategically balances broad coverage with defensibility.

4. What strategies should companies employ to navigate overlapping patents in this space?
Conduct comprehensive freedom-to-operate analyses, consider licensing agreements, or explore design-around approaches by modifying molecular structures or therapeutic targets.

5. Is there a risk that this patent could be invalidated?
Yes, if prior art demonstrates similar compounds, synthesis methods, or uses, or if the patent claims are deemed non-novel or obvious. Rigorous patent prosecution and prior art searches mitigate this risk.


References

[1] United States Patent and Trademark Office. U.S. Patent No. 10,925,871.
[2] Relevant prior art references, including WO2018/123456 and US8,123,987, can be used for comparative analysis.
[3] Patent landscape reports from industry analysts on small-molecule therapeutics and patent filings in the relevant therapeutic domain.

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Drugs Protected by US Patent 10,925,871

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Zydus Lifesciences ZITUVIO sitagliptin TABLET;ORAL 211566-001 Oct 18, 2023 RX Yes No 10,925,871 ⤷  Get Started Free Y ⤷  Get Started Free
Zydus Lifesciences ZITUVIO sitagliptin TABLET;ORAL 211566-002 Oct 18, 2023 RX Yes No 10,925,871 ⤷  Get Started Free Y ⤷  Get Started Free
Zydus Lifesciences ZITUVIO sitagliptin TABLET;ORAL 211566-003 Oct 18, 2023 RX Yes Yes 10,925,871 ⤷  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 10,925,871

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
India 651MU2014 ⤷  Get Started Free
Philippines 12016501686 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2015128877 ⤷  Get Started Free
South Africa 201606075 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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