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Last Updated: December 22, 2024

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): Usayapant; Arunya (Mundelein, IL), Ibrahim; Basma M. (Lincolnshire, IL)
Assignee: Fresenius Kabi USA, LLC (Lake Zurich, IL)
Application Number:15/700,258
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:

United States Patent 10,398,669: A Detailed Analysis of Scope and Claims

Overview of the Patent

The United States Patent 10,398,669, titled "Levothyroxine liquid formulations," pertains to the development and composition of liquid formulations of levothyroxine sodium, a medication used for thyroid replacement therapy. Here, we will delve into the key aspects of this patent, including its scope, claims, and the broader patent landscape.

Background and Purpose

Levothyroxine sodium is a synthetic form of the thyroid hormone thyroxine (T4), which is crucial for treating hypothyroidism and other thyroid-related conditions. The patent focuses on creating stable and effective liquid formulations of levothyroxine sodium, particularly useful for urgent or short-term thyroid replacement needs[1].

Scope of the Patent

The scope of the patent encompasses various aspects of levothyroxine liquid formulations, including:

Composition

The patent describes formulations that include levothyroxine sodium, along with other ingredients such as stabilizers, pH adjusting agents, and isotonicity adjusters. These formulations are designed to maintain the stability and bioavailability of levothyroxine sodium in a liquid form[1].

Methods of Preparation

The patent outlines methods for preparing these liquid formulations, including the steps involved in mixing the ingredients, adjusting the pH, and ensuring the isotonicity of the solution. This ensures that the final product is suitable for injection or oral administration[1].

Storage and Stability

The patent also addresses the storage conditions and stability of the formulations. It specifies the use of appropriate containers, such as glass ampules or plastic vials, and the conditions under which the formulations remain stable over time[1].

Claims of the Patent

The patent includes several claims that define the scope of the invention:

Independent Claims

  • Claim 1 describes the composition of the levothyroxine liquid formulation, including the concentration of levothyroxine sodium and other necessary ingredients.
  • Claim 8 details the method of preparing the formulation, including the steps and conditions required to ensure stability and efficacy[1].

Dependent Claims

  • These claims further specify various aspects of the composition and method, such as the types of stabilizers used, the pH range of the formulation, and the isotonicity adjusters employed[1].

Key Components and Ingredients

The patent highlights several key components and ingredients:

Levothyroxine Sodium

The primary active ingredient, levothyroxine sodium, is the focus of the patent. The formulations are designed to deliver this hormone in a stable and bioavailable form[1].

Stabilizers

Stabilizers such as trometamol (tris) and glycerol are used to maintain the stability of the levothyroxine sodium in the liquid formulation[1].

pH Adjusting Agents

The patent mentions the use of pH adjusting agents to ensure that the formulation has an appropriate pH, which is crucial for stability and bioavailability[1].

Isotonicity Adjusters

Isotonicity adjusters like sodium chloride or sodium iodide are included to ensure that the formulation is isotonic with bodily fluids, making it suitable for injection or oral administration[1].

Patent Landscape

The patent landscape for levothyroxine liquid formulations is characterized by several key factors:

Prior Art

The patent references prior art related to thyroid hormone formulations, highlighting the need for stable and effective liquid formulations of levothyroxine sodium. It distinguishes itself from existing formulations by its unique composition and method of preparation[1].

Competing Patents

Other patents related to thyroid hormone formulations exist, but they may differ in terms of composition, method of preparation, or specific applications. The unique claims of this patent ensure that it stands out in the patent landscape[1].

Regulatory Environment

The development and approval of pharmaceutical formulations like those described in this patent are heavily regulated. The patent must comply with regulatory standards for safety, efficacy, and stability, which are overseen by bodies such as the FDA[1].

Practical Applications

The practical applications of this patent are significant:

Urgent Thyroid Replacement

The liquid formulations are particularly useful when thyroid replacement is needed on an urgent basis, such as in emergency situations or when patients cannot take oral medications[1].

Short-Term Replacement

These formulations are also suitable for short-term thyroid replacement needs, providing a convenient and effective solution for patients[1].

Patient Compliance

Liquid formulations can improve patient compliance, especially for those who have difficulty swallowing tablets or capsules[1].

Industry Impact

The impact of this patent on the pharmaceutical industry is multifaceted:

Innovation in Formulations

The patent contributes to the innovation in pharmaceutical formulations, providing a stable and effective liquid form of levothyroxine sodium that can be used in various clinical settings[1].

Market Competition

The unique claims of this patent can give the patent holder a competitive edge in the market for thyroid hormone replacement therapies[1].

Patient Care

Ultimately, the patent improves patient care by providing a reliable and convenient form of thyroid hormone replacement, which can enhance treatment outcomes and patient quality of life[1].

Conclusion

The United States Patent 10,398,669 for levothyroxine liquid formulations is a significant contribution to the field of pharmaceuticals, particularly in the treatment of thyroid-related conditions. The patent's scope, claims, and practical applications highlight its importance in providing stable, effective, and convenient formulations for urgent and short-term thyroid replacement needs.

Key Takeaways

  • Stable Liquid Formulations: The patent describes stable and effective liquid formulations of levothyroxine sodium.
  • Unique Composition: The formulations include specific ingredients like stabilizers, pH adjusting agents, and isotonicity adjusters.
  • Practical Applications: Suitable for urgent and short-term thyroid replacement needs, improving patient compliance.
  • Industry Impact: Contributes to innovation in pharmaceutical formulations and provides a competitive edge in the market.
  • Regulatory Compliance: Must comply with regulatory standards for safety, efficacy, and stability.

FAQs

Q: What is the primary active ingredient in the patent 10,398,669?

A: The primary active ingredient is levothyroxine sodium.

Q: What are the key components used to stabilize the levothyroxine sodium in the liquid formulation?

A: Stabilizers such as trometamol (tris) and glycerol are used.

Q: Why are isotonicity adjusters important in the formulation?

A: Isotonicity adjusters ensure that the formulation is isotonic with bodily fluids, making it suitable for injection or oral administration.

Q: What are the practical applications of this patent?

A: The formulations are particularly useful for urgent or short-term thyroid replacement needs and can improve patient compliance.

Q: How does this patent impact the pharmaceutical industry?

A: It contributes to innovation in pharmaceutical formulations and provides a competitive edge in the market for thyroid hormone replacement therapies.

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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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632-002 Apr 11, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632-003 Apr 11, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>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 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2018102145 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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