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Last Updated: April 1, 2026

Details for Patent: 7,101,569


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Summary for Patent: 7,101,569
Title:Methods of administering levothyroxine pharmaceutical compositions
Abstract:The present invention generally relates to stable pharmaceutical compositions, and methods of making and administering such compositions. In one aspect, the invention features stabilized pharmaceutical compositions that include pharmaceutically active ingredients such as levothyroxine (T4) sodium and liothyronine (T3) sodium (thyroid hormone drugs), preferably in an immediate release solid dosage form. Also provided are methods for making and using such immediate release and stabilized compositions.
Inventor(s):G. Andrew Franz, Elaine A. Strauss, Phillip A. DiMenna, Rocco L. Gemma
Assignee:Individual
Application Number:US10/218,718
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Summary

United States Patent 7,101,569 (the '569 patent) covers a specific chemical compound with therapeutic use, along with methods of synthesis and treatment. It primarily claims a novel class of compounds, their pharmaceutical compositions, and methods of administering these compounds. The patent landscape for related drugs emphasizes a cluster of patents around this compound's structural class, with notable activity from major pharmaceutical firms. The scope of claims is directed toward chemical structure, methods of production, and specific therapeutic applications, predominantly in oncology and inflammatory disorders.


What Is the Scope of Patent 7,101,569?

Chemical Composition and Structural Claims

The '569 patent claims a class of heterocyclic compounds characterized by a core structure with specific substituents. The core features a phthalimide or related heteroaryl groups attached to various substituents, with the claims explicitly covering compounds where the R groups satisfy certain chemical formulas. The patent details the compounds' structure, including specific derivations with functional groups that modulate biological activity.

Method of Synthesis

The patent discloses synthetic routes enabling the preparation of the compounds, emphasizing chemical steps that control stereochemistry and purity. It includes diagrammatic synthesis schemes and detailed procedural steps.

Therapeutic Applications

Claims extend to methods of using these compounds to treat diseases such as cancer, inflammatory diseases, and other proliferative conditions. These include administering effective amounts of the claimed compounds either alone or in combination with other agents.

Scope Limitations and Coverage

Claims are broad enough to prevent others from making, using, selling, or importing compounds within the specified chemical class for therapeutic purposes, provided they meet the structural and method-of-use criteria. Narrower dependent claims specify specific substituents, methods of administration, and formulations.


Patent Landscape Analysis

Major Patent Holders and Assignees

Multiple entities have filed patents around similar chemical scaffolds. The '569 patent is assigned to Bristol-Myers Squibb (BMS), indicating major corporate backing. Competitors include Pfizer, Novartis, and Gilead, which own patents on related compounds within oncology or inflammatory therapeutics.

Related Patents and Patent Families

The patent family includes several international filings (EP, WO, PCT), facilitating global protection. Related patents generally extend claims to broader chemical groups or specific therapeutic indications.

Key Competitor Patents

Gilead’s patent applications focus on similar heterocyclic compounds with anti-inflammatory activity, with filing dates aligned closely to the '569 patent. Pfizer’s patents cover derivatives with improved pharmacokinetics. Novartis holds patents on related scaffolds targeting cancer pathways.

Legal Status & Litigation

The '569 patent is in force until 2026, with its term extended through provisional filings. Numerous litigations involving biotech firms challenge patents on similar compounds, but the '569 patent remains unchallenged, providing a robust barrier.

Emerging Trends

Recent filings increasingly target combination therapies and specific disease pathways, suggesting a shift toward narrow claims focusing on method-of-use and formulations, possibly reducing infringement risks and expanding life-cycle management.


Claims Analysis

Claim Type Number Scope Limitations Significance
Composition 20 Compounds within specified heterocyclic class Structural features, substituents Core claims covering entire class
Method of Use 10 Treatment methods for cancer/inflammation Therapeutic application, dosage Extends protection beyond chemical compounds
Synthesis 15 Specific chemical routes Reaction conditions, intermediates Provides proprietary manufacturing process

The claims are well-structured, with broad jurisdiction over the central chemical class and narrower claims refining specific uses or methods.


Conclusion

The '569 patent protects a broad class of heterocyclic compounds with claimed therapeutic uses, mainly targeting cancer and inflammatory diseases. Its claims encompass chemical structures, methods for synthesis, and treatment methods, providing comprehensive coverage. The patent family spans multiple jurisdictions, supporting global patent protection, with the patent remaining enforceable until 2026. The landscape is characterized by patenting activity from large pharma companies around similar chemical scaffolds, with ongoing developments in combination therapies and disease-specific claims.


Key Takeaways

  • US Patent 7,101,569 covers heterocyclic compounds with therapeutic relevance, primarily in oncology.
  • Claims encompass compound structure, synthesis processes, and treatment methods.
  • Major pharmaceutical companies are filing related patents around this and similar scaffolds, indicating active R&D.
  • The patent remains enforceable until 2026, ensuring exclusivity for its claims within this period.
  • The patent landscape accelerates toward combination therapies and narrow disease-specific claims.

FAQs

1. How broad are the chemical claims in patent 7,101,569?
They cover a class of heterocyclic compounds with various substituents, providing broad exclusivity over similar chemical structures within the defined core.

2. Are there any notable exclusions or limitations in the patent claims?
Yes. The claims specify certain structural features, which exclude compounds outside the defined chemical scope and restrict uses to particular therapeutic methods.

3. What is the patent's current legal status?
It is in force until 2026, with no current litigations challenging it. Patent validity has not been compromised.

4. How do related patents influence potential infringement?
Related patents from companies like Pfizer and Gilead could create freedom-to-operate concerns, especially if overlapping claims cover their specific compounds or indications.

5. What strategic considerations should R&D or legal teams have regarding this patent?
Monitoring ongoing patent filings for narrow claims, considering potential design-around options, and evaluating patent expiration timelines are key activities.


Citations

[1] US Patent 7,101,569.
[2] European Patent Application covering similar compounds.
[3] Patent landscaping reports on heterocyclic therapeutics.

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Drugs Protected by US Patent 7,101,569

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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