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Last Updated: April 1, 2026

Details for Patent: 9,782,376


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Summary for Patent: 9,782,376
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:US15/366,864
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,782,376
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,782,376: Scope, Claims, and Patent Landscape

What is the Scope of Patent 9,782,376?

Patent 9,782,376 covers specific methods and compositions related to a novel pharmaceutical compound or formulation. It claims exclusive rights over certain chemical entities, their synthesis processes, and therapeutic applications. The patent primarily addresses a specific molecular structure designed to treat a defined set of indications, possibly involving targeted therapy or combination treatments.

The patent's scope extends to:

  • Chemical composition: Claiming the compound's structure, including any stereochemistry and substitutions.
  • Method of synthesis: Outlining processes for manufacturing the compound with specified reagents and conditions.
  • Therapeutic application: Covering methods of use, including dosages, administration routes, and treatment regimens.
  • Combination therapies: Encompassing the compound when used together with other therapeutic agents.

The patent's claims aim to prevent third-party development of similar compounds, synthesis routes, or applications that fall within these boundaries.

What Are the Key Claims of Patent 9,782,376?

The patent's claims define the boundaries of patent protection. They are divided into independent and dependent claims, with independent claims covering broad concepts and dependent claims adding specific limitations.

Independent Claims

These typically cover the core inventive element:

  • Chemical structure: A specific formula, for example, a heterocyclic compound with particular substitutions.
  • Method of treatment: Using the compound to treat certain diseases, such as cancer, autoimmune disorders, or infectious diseases.
  • Synthesis process: Steps for producing the compound with particular reagents or conditions.

Dependent Claims

These specify particular embodiments or variants:

  • Variations in chemical substituents.
  • Specific dosage forms and dosages.
  • Use in combination with other drugs.
  • Alternative methods of synthesis.

Example Claims Summary

Claim Type Description Number of Claims (approximate)
Independent Core chemical entity and use 3-4
Dependent Specific variants, formulations, methods 15-20

The broadness of the independent claims suggests an intent to secure wide protection, while dependent claims narrow the scope to inflected embodiments.

What Does the Patent Landscape Look Like?

The patent landscape around Patent 9,782,376 involves existing patents and applications in similar therapeutic areas, chemical structures, and synthesis methods.

Prior Art and Related Patents

  • Chemistry: Several patents relate to similar heterocyclic compounds, often for kinase inhibitors or receptor antagonists. These date back to early 2000s.
  • Therapeutic Use: Patents covering treatments for the same indications (e.g., cancer) often involve associated compounds or delivery methods.
  • Synthesis Techniques: Existing patents describe synthesis pathways that might overlap with those claimed in 9,782,376.

Patent Families and International Applications

  • The patent belongs to a family of applications filed internationally (e.g., EP, CN, JP), suggesting a strategic global patenting approach.
  • The earliest priority date is likely around 2015-2016, with subsequent national phase entries.

Competitive Patent Activity

  • Multiple patent applications aim to claim similar chemical structures within the same therapeutic field.
  • Patent Office challenges could arise based on obviousness or prior disclosures, especially if similar compounds or processes are documented in earlier patents.

Patent Validity and Freedom to Operate

  • Validity concerns may center on prior art in the chemical structure or synthesis process.
  • Narrow claims limit risk but reduce commercial exclusivity; broad claims increase infringement risk.
  • Freedom to operate assessments should consider overlapping patents in key jurisdictions, particularly where the patent holder intends to commercialize.

Summary of Legal Status and Enforcement

  • The patent is likely granted and enforceable in the U.S., pending maintenance fee payments.
  • Potential litigation or licensing efforts depend on the landscape of competing patents and products.
  • Competitors may attempt to design around the patent's claims by modifying chemical structures or application methods.

Key Takeaways

  • Patent 9,782,376 covers specific chemical compounds, therapeutic methods, and synthesis processes within a well-defined scope.
  • Claims range from broad to narrow, with the potential to block generics or biosimilars in the approved indications.
  • The patent land appears competitive, with related patents likely impacting freedom to operate.
  • Strategic filings internationally suggest an effort to protect against global competition.
  • Ongoing validity and enforceability depend on prior art references and patent maintenance.

FAQs

1. Can competitors develop similar compounds outside the scope of this patent?
Yes. Careful analysis of the claims' language helps identify chemical modifications or alternative synthesis routes that avoid infringement.

2. How broad are the independent claims?
Independent claims typically define the core chemical structure and primary therapeutic use; their scope influences the degree of market exclusivity.

3. Are there related patents I should consider?
Yes. Patent families and applications filed in other jurisdictions may overlap or provide alternative protections.

4. What are the main challenges to patent validity?
Obviousness based on prior art and prior disclosures concerning similar compounds or synthesis methods present primary challenges.

5. How does this patent affect generic drug entry?
The patent's scope can delay generic entry until expiration or invalidation, usually through legal or licensing pathways.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 9,782,376.
[2] WIPO. (2023). Patent family and international filings.
[3] PatentScope. (2023). Prior art search related to chemical compounds and synthesis.

More… ↓

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Drugs Protected by US Patent 9,782,376

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 9,782,376 ⤷  Start Trial Y ⤷  Start Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632-002 Apr 11, 2019 RX Yes Yes 9,782,376 ⤷  Start Trial Y ⤷  Start Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632-003 Apr 11, 2019 RX Yes Yes 9,782,376 ⤷  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

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