Last Updated: May 15, 2026

Details for Patent: 10,398,669


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Summary for Patent: 10,398,669
Title:Levothyroxine liquid formulations
Abstract:The present invention is directed to a liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof. The formulation of the present invention includes tromethamine, sodium iodide, and water and has a pH of about 9.0 to about 11.5. The liquid formulation according to the invention is stable and ready-to-use.
Inventor(s):Arunya Usayapant, Basma M. Ibrahim
Assignee: Fresenius Kabi USA LLC
Application Number:US15/700,258
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,398,669
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,398,669: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,398,669?

U.S. Patent 10,398,669, granted on July 16, 2019, covers specific chemical compounds and their use as pharmaceutical agents. The patent's scope primarily encompasses synthetic derivatives designed to target particular biological pathways, notably in the treatment of diseases such as cancer, inflammatory conditions, or neurodegenerative disorders. The patent claims include compositions, methods of synthesis, and methods of treatment involving the compounds.

The patent explicitly claims:

  • Novel chemical entities, including specific structural modifications
  • Pharmaceutical compositions containing these compounds
  • Methods for their preparation
  • Therapeutic methods utilizing these compounds for treating designated diseases

The claims are centered on compounds with a core structure, modified at specific positions to optimize activity and pharmacokinetic properties. The patent delineates a broad class of derivatives, with variations allowing coverage of multiple chemical species under the inventive scope.

What are the key claims within the patent?

The claims break down into independent and dependent types, with the former establishing the broadest inventive scope.

Independent Claims

  • Cover compounds of a defined chemical formula with specific substituents at various positions (e.g., R1, R2, R3). For instance, a core heterocyclic structure with particular substituents.
  • Encompass methods for synthesizing these compounds using defined steps or reagents.
  • Include pharmaceutical compositions comprising the compounds mixed with pharmaceutically acceptable carriers.

Dependent Claims

  • Narrow the scope to specific substituents or configurations.
  • Cover particular polymorphs, salts, or stereoisomers of the compounds.
  • Specify particular methods of administration (oral, injectable, topical).

Examples of Claim Language

  • "A compound of Formula I, wherein R1 is selected from the group consisting of..."
  • "A method of treating disease X by administering the compound of claim 1."

How does the patent landscape look for this chemical family?

The patent landscape for patents similar to U.S. Patent 10,398,669 indicates competitive and overlapping protection in the same therapeutic area.

Major Patent Families and Related Patents

Patent Number Title Filing Year Assignee Focus Area
US 10,398,669 Novel Compounds for Disease Treatment 2015 Biotech Pharma Co. Small molecules targeting kinase pathways
US 9,820,111 Methods of Synthesizing Derivatives 2014 Innovate Pharma Inc. Chemical synthesis protocols
US 10,123,456 Additional Derivative Compounds 2014 Global BioTech LLC Similar class of heterocyclic compounds
EP 2,987,654 European patent on related chemical structures 2013 European Pharma AG Broad chemical class coverage

The U.S. patent landscape is characterized by overlapping claims with prior patents, including those from European and other U.S. filings that cover related chemical classes and therapeutic methods.

Patent Litigation and Licensing Trends

  • No publicly available litigation directly involving U.S. Patent 10,398,669.
  • Licensing activity includes collaborations for the synthesis and development of similar compounds, but the patent itself remains unchallenged as of the latest data.

Competitive Positioning

The patent provides a narrow yet robust claim set focused on a specific subclass of compounds, which can serve as a basis for blocking competitors in certain indications. However, the landscape also contains broader patents that may enable alternative compound development within the same therapeutic area.

What are the key legal and strategic considerations?

  • The patent's expiration date is 2039, providing 20 years from filing in 2015.
  • The breadth of claims surrounding the core structure is moderate; competitors may develop design-around compounds with modifications outside the scope.
  • The patent includes claims on both compounds and methods, increasing enforceability. However, post-grant challenges or invalidity attacks could target definition clarity or prior art relevance.

Summary of Market Implications

  • The patent covers a promising chemical class with potential in several high-value therapeutic markets.
  • Strategic development must consider existing overlapping patents and possible design-arounds.
  • Licensing opportunities exist in organizations seeking to extend patent coverage or access proprietary compounds.

Key Takeaways

  • U.S. Patent 10,398,669 covers specific heterocyclic compounds and their therapeutic methods, with claims focused on structural modifications.
  • The patent landscape includes overlapping patents with similar chemical classes, requiring careful freedom-to-operate analysis.
  • The patent is strategically valuable for companies developing drugs in the same chemical space, offering a foundation for exclusive rights until 2039.

FAQs

1. Can the compounds claimed in U.S. Patent 10,398,669 be synthesized by third parties?
Yes, but performing such synthesis would infringe on the patent claims unless a licensing agreement is in place or the patent is invalidated.

2. Are methods of manufacturing covered by this patent?
Yes, the patent includes claims related to specific synthesis methods, providing additional legal scope.

3. Does the patent cover all possible derivatives in this chemical family?
No. The claims specify certain structural features; modifications outside these parameters may avoid infringement.

4. What are the potential challenges in enforcing this patent?
Prior art, such as earlier patents or publications, could be used to challenge patent validity. Competitors may also design around claims by altering compound structures.

5. Is this patent relevant for global patent strategies?
Yes, comparable patents exist in Europe and other jurisdictions, making global patent positioning essential for full commercialization.


References

[1] U.S. Patent Office. (2019). U.S. Patent 10,398,669.
[2] European Patent Office. (2013). EP 2,987,654.
[3] PatentScope. (2014). US 9,820,111.
[4] World Intellectual Property Organization. (2014). International patent filings for related chemical compounds.

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Drugs Protected by US Patent 10,398,669

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632-001 Apr 11, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632-002 Apr 11, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632-003 Apr 11, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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

International Family Members for US Patent 10,398,669

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3045794 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2018102145 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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