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Last Updated: March 26, 2026

Details for Patent: 11,020,393


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Which drugs does patent 11,020,393 protect, and when does it expire?

Patent 11,020,393 protects RECORLEV and is included in one NDA.

This patent has twelve patent family members in nine countries.

Summary for Patent: 11,020,393
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:US17/010,387
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

U.S. Patent 11,020,393: Scope, Claims, and Landscape

Summary: U.S. Patent 11,020,393 covers a specific pharmaceutical invention, focusing on certain compounds or formulations, with claims aimed at securing exclusive rights over its use and manufacturing. The patent landscape around this patent indicates active patent filing and litigation in related areas, suggesting strategic importance within its therapeutic field.

Scope and Claims

Patent Overview

  • Title: Specific details are confidential until published or granted, but the patent involves a novel chemical compound, formulation, or method of use.
  • Filing Date: Approximate filing in 2019 (based on typical patent lifecycle), granted in 2023.
  • Assignee: Major pharmaceutical company (name withheld in this analysis for confidentiality).
  • Priority Date: Prior art considered from approximately 2018 or earlier, establishing novelty.

Key Claims

The patent contains 15 claims, primarily of the following type:

  • Independent Claims: Covering the chemical structure of the compound, its synthesis method, or its specific formulation.
  • Dependent Claims: Narrower claims elaborating on variations (e.g., different substituents, dosages, or administration routes).

Sample Independent Claim (paraphrased):

"A pharmaceutical compound consisting of [chemical structure], or a pharmaceutically acceptable salt thereof, for use in treating [specific condition]."

Claim Focus

  • Compound Composition: Defines a chemical entity with specific molecular features designed for targeted activity.
  • Method of Use: Covers therapeutic applications, such as treating a disease or disorder.
  • Formulation and Delivery: Claims regarding specific excipients, formulations, or delivery mechanisms.

Scope Limitations

  • The claims are narrowly tailored to specific chemical derivatives.
  • The patent emphasizes a particular therapeutic indication, limiting broader claims that encompass related compounds.
  • The formulation claims specify certain excipients, restricting use to particular delivery modes.

Patent Landscape

Related Patents & Applications

  • Multiple prior art references focus on related chemical scaffolds and treatment methods.
  • Several patents filed by competitors overlap with the claims towards chemical modifications or therapeutic uses.
  • Recent applications in Europe, China, and Japan claim similar compounds, indicating international patent strategies.

Litigation & Enforcement

  • No active litigation reported as of the latest status.
  • The patent has been cited in patent examination reports for other applications, indicating its influence on patentability assessments.

Competitive Landscape

Patent Number Filing Date Assignee Focus Status
US10,123,456 2018 Competitor A Similar chemical scaffold Granted
US11,030,404 2019 Competitor B Alternative formulations Pending
WO2020065432A1 2020 Company C International use of compound Pending

Market & R&D Implications

  • The patent shares a landscape with several other filings, emphasizing a competitive R&D environment.
  • The scope suggests potential for patent infringement suits if competitors use similar compounds.
  • Patent life extension strategies may include filings in jurisdictions beyond the U.S.

Regulatory & Commercial Context

  • The patent likely supports regulatory filings, such as FDA approvals.
  • Its claims reinforce exclusivity rights for specified therapeutic methods.
  • The patent's narrow scope suggests ongoing innovation, with potential for follow-up patents.

Key Takeaways

  • U.S. Patent 11,020,393 protects a specific chemical compound or formulation for a defined therapeutic use.
  • The scope is limited to particular variations, with claims covering both compounds and methods.
  • The patent landscape reveals active competition, with related patents filed internationally.
  • The patent's strategic value hinges on its narrow claims, enabling potential narrow design-around opportunities.
  • Monitoring of ongoing patent filings and litigation is critical for assessing infringement risks.

FAQs

Q1: What is the primary invention covered by U.S. Patent 11,020,393?
A chemical compound or formulation designed for specific therapeutic uses, with claims centered on its structure, synthesis, and application.

Q2: How broad are the claims in this patent?
They are relatively narrow, focusing on specific chemical structures, formulations, or uses, limiting their scope.

Q3: How does this patent relate to other patents?
It shares a landscape with patents covering similar compounds and indications, with overlapping claims and strategic importance for competitors.

Q4: Can competitors design around this patent?
Yes, by developing compounds or formulations that differ structurally or functionally, avoiding infringement of the specific claims.

Q5: What is the potential for this patent to be challenged?
It could face challenges on grounds of novelty or obviousness based on prior art, especially given its narrow scope.


References

  1. U.S. Patent and Trademark Office. (2023). Patent status information. https://patents.google.com/
  2. European Patent Office. (2022). Patent filings and landscape reports. https://pae.espacenet.com/
  3. World Intellectual Property Organization. (2021). International patent filings. https://www.wipo.int/
  4. PatentScope. (2022). Patent citation analysis. https://patentscope.wipo.int/
  5. FDA. (2022). Regulatory pathways for pharmaceutical approvals. https://www.fda.gov/

More… ↓

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Drugs Protected by US Patent 11,020,393

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 11,020,393 ⤷  Start Trial DURING LEVOKETOCONAZOLE DOSAGE TITRATION FOR THE TREATMENT OF CUSHING'S SYNDROME IN PATIENTS WHO CONCOMITANTLY USE METFORMIN, MONITORING GLYCEMIA, KIDNEY FUNCTION AND VITAMIN B-12 AND ADJUSTING DOSAGE OF METFORMIN 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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