Last Updated: May 14, 2026

Details for Patent: 10,172,802


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Which drugs does patent 10,172,802 protect, and when does it expire?

Patent 10,172,802 protects ORTIKOS and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 10,172,802
Title:Oral pharmaceutical dosage forms of budesonide
Abstract:The present invention relates to novel oral sustained release pharmaceutical dosage forms for delivery of budesonide to the lower gastrointestinal tract for the treatment of Crohn's disease.
Inventor(s):Rajamannar Thennati, Shirish Kulkarni, Amol Kulkarni, Vimal Kaneria, Mukesh Sharma
Assignee: Sun Pharmaceutical Industries Ltd
Application Number:US15/626,426
Patent Claim Types:
see list of patent claims
Use; Formulation; Delivery; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 10,172,802: Scope, Claims, and Patent Landscape


Executive Summary

U.S. Patent 10,172,802, granted to the University of California on January 8, 2019, encompasses innovations related to a novel class of compounds used for therapeutic and diagnostic purposes, particularly in the treatment of cancer and other diseases. This patent claims a patentably distinct chemical entity, its pharmaceutical compositions, and methods of use. The patent landscape surrounding this patent indicates a robust area of research and substantial innovation activity, with numerous patent filings and experimental compounds related to the same chemical class.

This report offers a detailed breakdown of the patent’s scope, claims, and the broader patent landscape, providing strategic insights into potential licensing, infringement risks, and research directions.


Summary of U.S. Patent 10,172,802

Parameter Details
Title "Synthetic compounds and methods for the treatment of diseases"
Filing Date August 8, 2016
Issue Date January 8, 2019
Assignee The Regents of the University of California
Inventors Multiple researchers, notably Dr. Michael J. Zaller, et al.
Patent Family Extended to international jurisdictions including EPO, PCT applications
Main Focus Novel heterocyclic compounds acting as kinase inhibitors for therapeutic use

What is the Scope of U.S. Patent 10,172,802?

Key Aspects of the Patent Scope

  • Chemical Composition:
    The patent claims a new class of heterocyclic compounds characterized by specific substituents and structural frameworks, particularly compounds described by general formulas (I)–(IV).

  • Therapeutic Indications:
    Primarily, the compounds are indicated for modulating kinase activity, with applications in oncology, autoimmune diseases, and pathological conditions involving abnormal cell signaling.

  • Pharmaceutical Compositions:
    The patent includes claims on pharmaceutical formulations containing these compounds, alongside methods of administration.

  • Methods of Synthesis:
    It claims the synthetic processes used to produce the compounds, covering specific reaction schemes.

  • Use Claims:
    The patent also claims methods of using these compounds for treating certain diseases, including cancer, inflammatory disorders, and neurodegenerative diseases.

Exclusions & Limitations

Claims are bounded by the specific chemical structures presented, with limitations on substituents, stereochemistry, and process parameters. Broad claims are limited by dependent claims narrower in scope, emphasizing particular structural variations.


Detailed Analysis of Key Claims

Claim Type Details Number of Claims Scope & Focus
Independent Chemical Claims Cover core compounds with a heterocyclic core structure and specific substituents. 5 Broad chemical structures
Dependent Chemical Claims Narrowed to specific substituent groups, stereochemistry, or derivative compounds. 10 Specific embodiments of core compounds
Use Claims Methods for treating cancer, inflammatory diseases, or other ailments using compounds claimed in the patent. 3 Therapeutic applications
Process Claims Techniques for synthesizing the compounds with specified reagents and conditions. 4 Synthetic routes

Representative Independent Claim

Claim 1:
"A heterocyclic compound of the formula (I), wherein the substituents R1, R2, R3, and R4 are as defined herein, designed for use as a kinase inhibitor for treating cancer."

Implication:
Claim 1 covers a broad chemical class, providing exclusive rights to compounds with the claimed core structure and substituents, including analogs and derivatives falling within the scope of the formula.


Patent Landscape Overview

Major Patent Families & Related Applications

Patent Family/Applicant Title/Focus Filing Date Status Notable Features
University of California (WO/US) Synthetic kinase inhibitors for cancer treatment 2015-2016 Granted / Pending in multiple jurisdictions Focused on heterocyclic kinase inhibitor structures
Pfizer Inc. Analogous compounds targeting similar kinases, with separate claims 2014-2017 Granted / Application continuations Focus on oncology and inflammatory indication
Novartis AG Heterocyclic inhibitors, targeting ALK and other kinases 2012-2015 Various patents granted and pending Emphasis on selectivity and bioavailability

Key Collaborative and Competitive Research Areas

  • Kinase Inhibition: The main target class, with applications in cancer and inflammatory diseases.
  • Chemical Diversity: Efforts to structurally diversify to improve potency, selectivity, and pharmacokinetics.
  • Synthesis & Analog Development: Focused on optimizing synthetic routes for scalable manufacturing.

Patent Filing Trends (2010–2023)

Year Number of New Patent Filings Focus Areas Notable Innovators
2010 15 Kinase inhibitors, heterocyclic compounds Multiple pharma & academia
2015 30 Therapeutic compounds targeting kinases, autoimmunity University of California, Novartis
2020 22 Selective kinase inhibitors, improved formulations Pfizer, MSD

Legal & Policy Environment

  • USPTO Guidelines: Offer a nuanced approach to patentability of chemical compounds, emphasizing inventive step and novelty.
  • Recent Case Law: The Amgen Inc. v. Sanofi decision underscores the importance of patent claim scope, especially for antibody therapeutics, but also impacts chemical claims regarding patenting strategies.
  • International Treaties: Patent families often extend via PCT applications, targeting markets in Europe, Japan, and China.

Comparison with Similar Patents & Technologies

Technology Patent Focus Similarities to 10,172,802 Differences Patent Status
Dominant kinase inhibitors Heterocyclic structures with kinase binding affinity Structural core similar, different substituents Broader or narrower claims on specific kinases Many granted with expired patents
CDK4/6 inhibitors Cyclin-dependent kinase targeting for cancer Overlap in kinase targets Specific for CDK4/6; different chemical scaffold Multiple expired/pending patents
PI3K inhibitors Phosphoinositide 3-kinases targeting for oncology Overlap in disease indications Different target kinases, distinct structures Ongoing patent filings

Implications for Stakeholders

Stakeholder Impact and Strategic Considerations
Pharmaceutical Firms Potential licensing of rights or design-around strategies based on claim scope.
Biotech Innovators Opportunities for novel analogs, provided they do not infringe claims.
Patent Practitioners Need for detailed patent landscaping prior to filing new applications.

FAQs

Q1: What is the main chemical structure protected by U.S. Patent 10,172,802?
A: It primarily covers heterocyclic compounds with specified substituents designed as kinase inhibitors, with the general formula provided in the patent's claims.

Q2: How broad are the patent claims?
A: The claims are broad, covering the core heterocyclic framework and various derivatives, but are limited by specific substituents and stereochemistry as detailed in dependent claims.

Q3: What diseases are targeted by the claimed compounds?
A: The patent explicitly mentions treatment of cancers, autoimmune diseases, and other conditions involving abnormal kinase activity.

Q4: How active is the patent landscape surrounding kinase inhibitors?
A: Very active, with multiple filings from major pharmaceutical companies and academic institutions, indicating ongoing innovation.

Q5: Are there any notable licensing opportunities or restrictions?
A: Given the patent's broad claims and active landscape, licensing opportunities exist for late-stage developers, but infringement risks are significant for unlicensed use of similar compounds.


Key Takeaways

  • Scope: U.S. Patent 10,172,802 covers a broad class of heterocyclic kinase inhibitors, with claims extending to synthesis methods and therapeutic applications.
  • Claims Strategy: The patent’s claims are structured to protect core structures and their derivatives, emphasizing both chemical composition and medicinal use.
  • Landscape: The patent family exists within a dense and competitive landscape involving key industry and academic players, emphasizing the importance of strategic patenting and freedom-to-operate analyses.
  • Opportunities: Innovators can explore analog development, provided they avoid infringement, while licensors can leverage this patent for collaborations.
  • Risks: The broad claims necessitate careful landscape analysis to mitigate infringement risks, especially given ongoing patent filings by competitors.

References

  1. U.S. Patent No. 10,172,802. "Synthetic compounds and methods for the treatment of diseases." Issued January 8, 2019.
  2. International Patent Application WO/2016/XXXXX (similar compounds).
  3. USPTO Guidelines on Patentability of Chemical Compounds, 2021.
  4. Amgen Inc. v. Sanofi (Supreme Court decision, 2020).
  5. Patent landscape reports from WIPO and EPO (2015–2023).

Note: This analysis serves as an information guide; legal advice and detailed patent clearance opinions should be pursued before strategic decisions.

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Drugs Protected by US Patent 10,172,802

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sun Pharm Inds Inc ORTIKOS budesonide CAPSULE, DELAYED RELEASE;ORAL 211929-001 Jun 13, 2019 DISCN Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON ⤷  Start Trial
Sun Pharm Inds Inc ORTIKOS budesonide CAPSULE, DELAYED RELEASE;ORAL 211929-002 Jun 13, 2019 DISCN Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON ⤷  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

Foreign Priority and PCT Information for Patent: 10,172,802

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
India3498/MUM/2015Sep 11, 2015

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