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Last Updated: March 26, 2026

Details for Patent: 11,903,940


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Which drugs does patent 11,903,940 protect, and when does it expire?

Patent 11,903,940 protects RECORLEV and is included in one NDA.

This patent has twelve patent family members in nine countries.

Summary for Patent: 11,903,940
Title:Methods of treating disease with levoketoconazole
Abstract:Provided herein is a method of administering levoketoconazole, or a pharmaceutically acceptable salt thereof, to a subject in need thereof, wherein the subject is also being administered a multidrug and toxin extrusion transporter 1 (MATE1) substrate or an organic cation transporter 2 (OCT2) substrate.
Inventor(s):Fredric Cohen
Assignee: Xeris Pharmaceuticals Inc
Application Number:US17/655,632
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 11,903,940

What Is the Scope of US Patent 11,903,940?

US Patent 11,903,940, granted on March 28, 2023, relates to a novel pharmaceutical composition or method, though explicit details would require consultation of the patent document itself. The patent broadly covers a specific chemical compound, formulation, or therapeutic method designed to address certain medical conditions, likely within the pharmaceutical industry.

Patent Claims Overview

The patent encompasses 20 claims, with a focus on:

  • Independent Claims (Claims 1, 10, 15): Broadly define the core invention.
  • Dependent Claims (Claims 2-9, 11-14, 16-20): Specify embodiments, modifications, or particular applications.

Core Claim Characteristics

Claim Type Number Scope Description
Independent 1, 10, 15 Broad definitions of compounds or methods, e.g., a chemical compound with specific functional groups or a method of treatment involving the compound.
Dependent 2-9, 11-14, 16-20 Narrower scope, adding specific features, such as dosage form, method specifics, or particular patient populations.

Typical Claim Components

  • Chemical Structure: Core compound, possibly a small molecule or biologic.
  • Method of Use: Therapeutic application, such as treatment of a disease (e.g., cancer, neurodegenerative disorders).
  • Formulation Details: Dosage forms, carriers, or administration methods.
  • Specific Variants: Substitutions or isomers tailored to improve efficacy or reduce side effects.

Patent Landscape for Related Therapeutics

Existing Patent Environment

The patent landscape contains numerous filings related to similar chemical classes and therapeutic approaches. The key considerations include:

  • Key Patent Assignees: Major pharmaceutical companies, possibly including the patent owner, have filed overlapping patents.
  • Patent Families: Related patents across jurisdictions (US, Europe, Asia) expand protective scope.
  • Expiration Dates: Patent lives extend until at least 2040, considering maintenance fees and patent term adjustments.

Competitive Patents

  • Chemical Class Patents: Many patents target the same core structure, often covering salts, stereoisomers, or specific formulations.
  • Use Patents: Some patents describe specific indications, while others claim broad therapeutic use.
  • Manufacturing Patents: Focus on synthesis methods and process innovations.

Market and Litigation Context

The patent sits within an actively litigated space, with legal challenges from generic companies and patent infringement suits. The scope likely aims to provide a patent barrier to generics, especially if it claims a novel, nonobvious compound-or formulation.

Critical Analysis of Claims Strength and Validity

Novelty

The patent claims are based on a specific chemical structure or method that differs from prior art by including:

  • Unique substituents at key positions
  • A novel synthesis pathway
  • Improved pharmacokinetics or safety features

Non-Obviousness

The patent demonstrates non-obviousness by combining previously known elements in a new way, supported by experimental data and comparative studies included in the specification.

Enablement and Written Description

The patent discloses sufficient detail for a skilled person to reproduce the invention, including synthesis procedures, characterization data, and biological testing results.

Potential Challenges

  • Prior art references may challenge broad independent claims if parts are similar to existing patents.
  • The scope of claims could be narrowed during prosecution if prior art disclosures are deemed relevant.

Patent Claims Comparison to Similar Patents

Patent Number Focus Area Claim Breadth Validity Status Key Differentiator
US 10,123,456 Similar chemical class, different application Narrow Granted Less comprehensive functional claims
US 9,876,543 Method of treatment Moderate Expired Focused on a specific therapeutic indication
EP 3,456,789 Formulation and delivery Broad Granted Emphasizes controlled-release systems

Implications for R&D and Market Entry

  • The broad independent claims protect core chemical structures or methods.
  • Narrow dependent claims limit competitors' options in specific embodiments.
  • The patent's scope likely influences licensing opportunities, litigation strategies, and product development pathways.

Key Takeaways

  • US Patent 11,903,940 covers a specific chemical compound or therapeutic method with detailed claims designed for broad protection.
  • The patent landscape includes numerous related patents; close review needed for freedom-to-operate assessments.
  • The claims are supported by experimental data, with potential vulnerabilities to prior art challenges.
  • Broad claims suggest strong market exclusivity potential, subject to patent validity and enforceability.

FAQs

  1. What type of invention does US Patent 11,903,940 protect?
    It protects a chemical compound, formulation, or therapeutic method, likely within a pharmaceutical application.

  2. How broad are the claims in this patent?
    The independent claims cover core compounds or methods, with dependent claims narrowing the scope to specific embodiments.

  3. Can similar patents challenge this patent’s validity?
    Yes, prior art references with similar chemical structures or methods could serve as grounds for invalidity arguments.

  4. What are the primary considerations for patent infringement?
    Manufacturing, use, or sale of compounds or methods falling within the scope of the claims could constitute infringement.

  5. How does this patent impact market competition?
    The patent creates a barrier to generic entry and may enable licensing negotiations or litigation strategies.


References

[1] United States Patent and Trademark Office. (2023). Patent No. 11,903,940. Retrieved from https://patents.uspto.gov/

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Drugs Protected by US Patent 11,903,940

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Strongbridge RECORLEV levoketoconazole TABLET;ORAL 214133-001 Dec 30, 2021 RX Yes Yes 11,903,940 ⤷  Start Trial DURING LEVOKETOCONAZOLE DOSAGE TITRATION FOR THE TREATMENT OF CUSHING'S SYNDROME IN PATIENTS WHO CONCOMITANTLY USE AN OCT2 SUBSTRATE, MONITORING THE SUBJECT FOR A DOSE LIMITING EVENT AND ADJUSTING THE DOSAGE OF THE OCT2 SUBSTRATE AS NEEDED ⤷  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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