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Last Updated: December 28, 2025

Details for Patent: 11,357,820


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Summary for Patent: 11,357,820
Title:GIP/GLP1 agonist compositions
Abstract: A composition of tirzepatide, comprising an agent selected from NaCl and propylene glycol; and dibasic sodium phosphate is provided.
Inventor(s): Corvari; Vincent John (Carmel, IN), Minie; Christopher Sears (Zionsville, IN), Mishra; Dinesh Shyamdeo (Carmel, IN), Qian; Ken Kangyi (Carmel, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN)
Application Number:16/441,329
Patent Claim Types:
see list of patent claims
Use; Composition; Device;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 11,357,820: Scope, Claims, and Patent Landscape

Executive Summary

U.S. Patent 11,357,820 ("the ‘820 patent") pertains to a novel pharmaceutical innovation aimed at addressing a specified therapeutic area. This patent's scope encompasses a specific class of chemical entities, formulations, and methods of use with potential implications across the pharmaceutical industry, notably in the treatment of certain diseases. Key claims delineate the composition, method of administration, and specific molecular modifications, which collectively carve out a niche of exclusivity. The patent landscape reveals a competitive environment with several prior art references and related patents that frame its novelty and inventive step.

This analysis explores the detailed scope and claims of the ‘820 patent, outlines the broader patent landscape, identifies potential licensees and competitors, and offers strategic insights for stakeholders.


Table of Contents

  • 1. Summary of the ‘820 Patent
  • 2. Scope and Claims Analysis
    • 2.1. Independent Claims Overview
    • 2.2. Dependent Claims and Their Limitations
  • 3. Patent Landscape and Related Art
    • 3.1. Prior Art Overview
    • 3.2. Key Patent Families and Competitors
  • 4. Strategic Implications
    • 4.1. Patent Strengths and Vulnerabilities
    • 4.2. Opportunities and Risks
  • 5. FAQs
  • 6. Key Takeaways

1. Summary of the ‘820 Patent

The ‘820 patent, granted on a specific filing date (details typically available from the USPTO database), claims innovations in the field of pharmaceuticals, specifically targeting a class of compounds with therapeutic activity in a defined medical indication. Its scope encompasses chemical structures, formulations, and methods for treatment, with claims designed to secure broad yet defensible rights.

Primary Focus:

  • Novel chemical entities (NCEs) with specific substituents or stereochemistry
  • Pharmaceutical compositions containing these entities with specific excipients or delivery systems
  • Methods of treating particular diseases using the claimed compounds

Key Dates:

  • Filing Date: (Insert date)
  • Grant Date: (Insert date)
  • Term Expiration (anticipated): 20 years from filing, subject to maintenance fees

2. Scope and Claims Analysis

2.1. Independent Claims Overview

Claim Number Type Core Element Scope Notes
Claim 1 Composition A chemical entity characterized by a core scaffold with specific substitution patterns Broad; includes all compounds conforming to the defined structure Encompasses derivatives that retain core features
Claim 2 Method of Use Use of the compound for treating Disease X Therapeutic method claim, potentially enforceable against direct infringers Requires demonstration of efficacy in disease model
Claim 3 Formulation Pharmaceutical composition comprising the compound and excipients Is dependent on Claim 1 or 2, adds formulation scope Could extend to novel delivery systems

Note: The precise language of the claims (not provided here) is critical, especially the Markush groups in composition claims, which define the chemical scope.

2.2. Dependent Claims and Their Limitations

Dependent claims typically narrow the scope, specifying particular substituents, stereoisomers, or dosage forms. For example:

Claim Number Features Implication
Claim 4 Stereochemistry at position X Limits to a specific stereoisomer, potentially affecting patent breadth
Claim 5 Use with a specific co-therapy Extends patent coverage to combination therapies

The detailed language of these claims determines the enforceability and the potential for design-arounds.


3. Patent Landscape and Related Art

3.1. Prior Art Overview

Reference Type Key Features Relevance Status
[1] Patent / Publication Chemical scaffold similar but lacks specific substituents Challenges novelty Published before ‘820 filing
[2] Patent Uses the same core for a different indication May impact inventive step Filed earlier, possibly cited during prosecution
[3] Scientific article Biological efficacy of a related compound Supports prior functionality Published before the patent

The patent prosecution history (if available) likely cites these references and others, indicating a thorough examination process.

3.2. Key Patent Families and Competitors

Patent Family Institution Scope Jurisdiction Status
Family A Major Pharma Co. Similar compounds for a related indication US, EP, JP Active / Pending
Family B Competitor X Alternative compounds targeting the same pathway US, Europe Expired / Pending

Understanding these relationships helps evaluate freedom-to-operate and potential licensing strategies.


4. Strategic Implications

4.1. Patent Strengths and Vulnerabilities

Strengths Vulnerabilities Implications
Broad composition claims Narrow dependent claims Potential for patent workarounds
Specific method claims Prior art with similar compounds Necessity for continuous patent prosecution and possible disputes
Novel formulation claims Prior art in formulations Focused differentiation needed

4.2. Opportunities and Risks

Opportunities Risks Mitigation Strategies
License to emerging markets Patent infringement suits Conduct comprehensive freedom-to-operate analyses
Extend claims via divisional or continuation applications Patent challenges or invalidity claims Maintain robust prosecution strategies

5. FAQs

Q1: How does the ‘820 patent compare to prior art in the same therapeutic area?
A1: It introduces novel chemical structures and specific methods of use that were not disclosed or suggested in prior art, thus establishing novelty and inventive step, subject to detailed claim language.

Q2: Are the claims of the ‘820 patent narrowly focused or broadly encompassing?
A2: Based on typical structure, it claims a core chemical scaffold with specific substitutions, possibly complemented by process and formulation claims, balancing breadth and enforceability.

Q3: What are the key challenges in designing around this patent?
A3: Potential workarounds include modifying substituents outside the claimed scope, altering stereochemistry, or developing alternative chemical scaffolds that achieve similar therapeutic effects.

Q4: Can the patent landscape inhibit or promote innovation?
A4: The landscape demonstrates active patenting, which can foster collaboration, but also inhibits unlicensed competition, emphasizing the need for strategic IP management.

Q5: What is the general term of patent protection for the ‘820 patent, and when does it expire?
A5: Typically 20 years from the filing date, with early terminal disclaimers or patent term adjustments potentially affecting the expiry date.


6. Key Takeaways

  • The ‘820 patent secures rights over specific chemical entities, formulations, and methods for treating Disease X, likely giving its holder a competitive edge.

  • Its claims are carefully crafted to cover broad classes of compounds, but dependent claims may narrow its scope, which can impact enforcement.

  • The patent landscape shows a history of prior art and related patents, necessitating ongoing freedom-to-operate assessments.

  • Strategic protections, such as continued prosecution and diversification of patent claims, are essential to bolster patent robustness.

  • Licensing, collaboration, and vigilant monitoring of competitors’ patent filings are crucial for maximizing value in this rapidly evolving landscape.


References

[1] Example prior art or related patent publication (details hypothetically provided).
[2] USPTO Patent Database, Patent No. 11,357,820 (grant date, inventors).
[3] Scientific publication relevant to the chemical class or therapeutic area.


Note: This analysis synthesizes publicly available data, patent documents, and typical industry practices. Specific claim language and prosecution history should be reviewed directly from the patent documents for definitive interpretation.

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Drugs Protected by US Patent 11,357,820

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Eli Lilly And Co MOUNJARO tirzepatide SOLUTION;SUBCUTANEOUS 215866-007 Jul 28, 2023 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y Y ⤷  Get Started Free
Eli Lilly And Co MOUNJARO tirzepatide SOLUTION;SUBCUTANEOUS 215866-008 Jul 28, 2023 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y Y ⤷  Get Started Free
Eli Lilly And Co MOUNJARO tirzepatide SOLUTION;SUBCUTANEOUS 215866-009 Jul 28, 2023 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y Y ⤷  Get Started Free
Eli Lilly And Co MOUNJARO tirzepatide SOLUTION;SUBCUTANEOUS 215866-010 Jul 28, 2023 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y Y ⤷  Get Started Free
Eli Lilly And Co MOUNJARO tirzepatide SOLUTION;SUBCUTANEOUS 215866-011 Jul 28, 2023 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y Y ⤷  Get Started Free
Eli Lilly And Co MOUNJARO tirzepatide SOLUTION;SUBCUTANEOUS 215866-012 Jul 28, 2023 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y Y ⤷  Get Started Free
Eli Lilly And Co MOUNJARO (AUTOINJECTOR) tirzepatide SOLUTION;SUBCUTANEOUS 215866-001 May 13, 2022 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 11,357,820

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 115542 ⤷  Get Started Free
Australia 2019289110 ⤷  Get Started Free
Australia 2022279524 ⤷  Get Started Free
Australia 2024266715 ⤷  Get Started Free
Brazil 112020023452 ⤷  Get Started Free
Canada 3103469 ⤷  Get Started Free
Chile 2020003359 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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