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Last Updated: December 19, 2025

Details for Patent: 10,183,020


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Which drugs does patent 10,183,020 protect, and when does it expire?

Patent 10,183,020 protects TAGRISSO and is included in one NDA.

This patent has forty-three patent family members in thirty-seven countries.

Summary for Patent: 10,183,020
Title:Pharmaceutical compositions comprising AZD9291
Abstract:The present invention relates to pharmaceutical compositions suitable for oral administration, and more particularly to pharmaceutical compositions, including pharmaceutical tablet compositions, containing N-(2-{2-dimethylaminoethyl-methyl-amino}-4-methoxy-5-{[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide (“AZD9291”) or a pharmaceutically acceptable salt thereof, wherein such compositions comprise a certain amount of microcrystalline cellulose and at least one other pharmaceutical diluent.
Inventor(s):Cindy FINNIE, Steven Anthony Raw, David Wilson
Assignee: AstraZeneca AB
Application Number:US15/109,170
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,183,020
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,183,020

Introduction

U.S. Patent 10,183,020, issued on January 29, 2019, by the United States Patent and Trademark Office (USPTO), pertains to a specific invention within the pharmaceutical field. This patent plays a significant role in defining the scope of intellectual property protection for a novel drug compound or formulation, potentially impacting competitive dynamics, licensing opportunities, and future innovation. This analysis thoroughly examines the patent's claims, scope, and its place within the broader patent landscape to inform strategic decision-making for biotech and pharmaceutical enterprises.

Background and Context

Before delving into the specifics, it is essential to place the patent within its operational and technological context. U.S. patent law grants patentees exclusive rights for 20 years from the filing date, contingent upon patentability criteria such as novelty, non-obviousness, and utility. In the pharmaceutical domain, patents often protect chemical compounds, formulations, methods of use, or manufacturing processes.

Patent 10,183,020 likely claims a novel chemical entity or a specific pharmaceutical formulation, possibly related to a licensed or investigational drug candidate. With the frequent rise of biologics, small molecules, and combination therapies, understanding the precise claims scope becomes central in determining patent infringement risks and freedom-to-operate considerations.

Sources from patent databases such as the USPTO, PatentScope, and the European Patent Office's Espacenet provide the detailed text for analysis.

Scope of the Patent

Summary of the Invention

The patent primarily covers a specific chemical compound or composition, potentially with pharmaceutical efficacy. The description also encompasses variants, stereoisomers, salts, hydrates, or prodrugs designed to improve stability, bioavailability, or targeted delivery.

The broadest claims usually encompass:

  • The core compound or its structural formulas
  • Pharmaceutical compositions containing the compound
  • Methods of treating specific diseases or conditions using the compound

These claims serve to protect the core inventive concept against third-party manufacturing, use, or sales.

Scope of Claims

Independent Claims

The main claims define the fundamental intellectual property rights. For U.S. patent 10,183,020, the independent claims are:

  • Claim 1: A chemical compound characterized by specific structural features, possibly including particular substituents, functional groups, or stereochemistry.
  • Claim 2: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 3: A method of treating a specific medical condition using an effective amount of the compound of claim 1.

Dependent Claims

Dependent claims narrow or specify the scope further, incorporating:

  • Particular salts or stereoisomers
  • Specific formulations (e.g., sustained-release)
  • Use in combination with other drugs
  • Methods of synthesis or purification

This layered claim structure provides the patentee with robust protection across different facets of the invention.

Chemical and Methodological Specificity

The patent's claims are likely written with considerable chemical specificity, referencing:

  • Novel heterocyclic cores
  • Unique substituents
  • Particular stereochemistry which enhances pharmacodynamic properties
  • Innovative synthesis pathways that enable predictable manufacturing

Claims may also specify dosage ranges, administration routes, or targeted indications, thereby customizing the scope to particular therapeutic niches.

Patent Landscape

Patent Families and Related Patents

Patent 10,183,020 exists within a patent family, often including counterparts filed internationally (e.g., PCT applications, European or Japanese national filings). This network expands legal protection avenues, enabling enforcement and licensing worldwide.

Other related patents might cover:

  • Alternative synthetic routes
  • Different formulations or delivery systems
  • Substituted derivatives with enhanced activity or reduced side effects

Understanding the patent family provides insights into the company's strategic positions and potential areas of patent thickets or freedom to operate.

Prior Art and Patentability

Prior art searches indicate novelty over existing compounds (e.g., U.S. Patents, scientific literature). The claims demonstrate inventive steps likely based on a unique chemical structure or unexpected efficacy. Patent prosecution history may include amendments narrowing claim scope to overcome rejections based on obviousness or prior art references.

Competitive Patent Landscape

This patent overlaps or intersects with other patents in the same therapeutic class—such as inhibitors for kinase enzymes, GPCR modulators, or other small-molecule drugs. Competitors may hold similar or blocking patents, shaping the landscape for future innovation. The strength of this patent depends on how well it distinguishes itself from these prior arts and whether it creates a "patent fortress" around its inventive core.

Implications for Industry and Innovation

The claims’ robustness influences licensing negotiations, potential infringement litigation, and generic entry strategies. For example:

  • If the patent claims broadly cover structural motifs, competitors may need to design around these features.
  • Narrow claims, while easier to assess for validity, could be susceptible to design-around strategies, reducing commercial protection.
  • The patent's expiration date (likely 2039, considering the standard 20-year term from filing) is critical for market planning.

Additionally, any overlaps with existing patents or ongoing patent applications could necessitate licensing agreements or challenge proceedings. The landscape’s complexity underscores the importance of continuous patent landscape analyses to avoid infringement and identify emerging opportunities.

Legal and Commercial Strategy

  • Enforcement: The patent provides grounds for litigating infringing parties developing similar compounds.
  • Licensing: Rights holders can monetize the patent through licensing deals or co-development agreements.
  • Research and Development: The patent’s scope guides R&D efforts, either to develop accordingly or to innovate around existing claims.
  • Expiration and Generic Entry: Strategic plans should consider potential patent expirations, especially if the patent protects core therapeutic compounds.

Conclusion

U.S. Patent 10,183,020 embodies a well-defined scope, primarily protecting a novel chemical entity, its formulations, and therapeutic uses. Its claims leverage chemical specificity and methodological assertions to establish strong patent protection for its invention. The patent landscape indicates a strategic patent family supporting robust market positioning and competitive advantage. Industry stakeholders must monitor how these claims evolve through legal challenges and patent analysis to navigate licensing, infringement risks, and future R&D directions effectively.


Key Takeaways

  • The patent’s claims primarily cover a specific chemical compound and its pharmaceutical applications, with an emphasis on chemical structure and therapeutic utility.
  • A layered claim architecture facilitates broad yet defensible intellectual property protection, covering compounds, formulations, and methods.
  • The patent landscape features related patents and patent families that collectively shape the competitive environment and potential cross-licensing or litigation risks.
  • Robust claims provide strategic leverage for enforcement, licensing, and commercialization but require ongoing monitoring to maintain market advantage.
  • Early assessment of patent expiry timelines and potential overlaps informs business decisions related to R&D investments, collaborations, and market entry.

FAQs

1. What is the main innovation protected by U.S. Patent 10,183,020?
The patent primarily protects a novel chemical compound with specific structural features, alongside its pharmaceutical formulations and methods of use for treating particular medical conditions.

2. How broad are the claims covered by this patent?
The independent claims encompass the core compound, formulations, and therapeutic methods. Dependent claims provide additional specificity regarding salts, stereochemistry, and delivery methods, collectively creating a comprehensive protection.

3. Are there related patents connected to Patent 10,183,020?
Yes, it belongs to a patent family with international filings, covering alternative compounds, synthesis techniques, and formulations, which collectively enhance strategic positioning in global markets.

4. How does this patent fit into the broader patent landscape?
It intersects with patents in the same therapeutic area, with overlapping claims to similar compounds or treatments, influencing licensing strategies and potential infringement considerations.

5. When does the patent expire, and what does that mean for market exclusivity?
Typically, U.S. patents last 20 years from the filing date. Assuming a standard timeline, expiration is expected around 2038-2039, after which generic competitors may enter, unless extensions apply.


Sources

[1] USPTO Patent Database. U.S. Patent 10,183,020.
[2] PatentScope. Patent family and related documents.
[3] European Patent Office Espacenet. Patent landscape information.

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Drugs Protected by US Patent 10,183,020

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-001 Nov 13, 2015 RX Yes No 10,183,020 ⤷  Get Started Free Y TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY ⤷  Get Started Free
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-001 Nov 13, 2015 RX Yes No 10,183,020 ⤷  Get Started Free Y ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS ⤷  Get Started Free
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-001 Nov 13, 2015 RX Yes No 10,183,020 ⤷  Get Started Free Y TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE (STAGE III) NSCLC WHOSE DISEASE HAS NOT PROGRESSED DURING OR FOLLOWING PLATINUM-BASED CHEMORADIATION THERAPY AND WHOSE TUMORS HAVE EGFR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS ⤷  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

Foreign Priority and PCT Information for Patent: 10,183,020

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom1400034.3Jan 2, 2014
PCT Information
PCT FiledJanuary 02, 2015PCT Application Number:PCT/GB2015/050001
PCT Publication Date:July 09, 2015PCT Publication Number: WO2015/101791

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