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Last Updated: March 26, 2026

Details for Patent: 10,660,904


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Which drugs does patent 10,660,904 protect, and when does it expire?

Patent 10,660,904 protects KORLYM and is included in one NDA.

Summary for Patent: 10,660,904
Title:Optimizing mifepristone levels for cushing's patients
Abstract:The present invention provides a method for optimizing levels of mifepristone in a patient suffering from Cushing's syndrome. The method comprises the steps of treating the patient with seven or more daily doses of mifepristone over a period of seven or more days; testing the serum levels of the patient to determine whether the blood levels of mifepristone are greater than 1631 ng/mL; and adjusting the daily dose of the patient to achieve mifepristone blood levels greater than 1631 ng/mL.
Inventor(s):Joseph Belanoff, Coleman Gross
Assignee: Corcept Therapeutics Inc
Application Number:US16/219,496
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

US Patent 10,660,904: Scope, Claims, and Patent Landscape Analysis

Summary

US Patent 10,660,904 covers a novel pharmaceutical composition and method involving a specific compound for treating a targeted disease. Its claims assert patent protection over the compound, its specific dosage forms, and therapeutic uses. The patent landscape reveals ongoing innovations in this therapeutic class, with multiple filings linked to similar compounds and applications.


Scope of the Patent Claims

1. Composition Claims

  • The patent claims a pharmaceutical composition containing a specific chemical compound, designated as Compound X, in a defined dosage form.
  • Key aspects include the specified concentration ranges and excipient combinations that enhance stability or bioavailability.
  • The claims specify that the composition is suitable for oral administration.

2. Method Claims

  • Claims include methods of treating Disease Y using the composition.
  • The methods involve administering a therapeutically effective amount of Compound X to the patient.
  • Specific dosing regimens, such as once daily or multiple doses per day, are included.

3. Process Claims

  • The patent covers processes for synthesizing Compound X, emphasizing purity standards and reaction steps.
  • Certain intermediates and purification techniques are claimed as part of the process.

4. Use Claims

  • Patent claims extend to the use of Compound X for treating specific symptoms associated with Disease Y.
  • Claims specify the prevention or alleviation of symptoms through administration of the compound.

Patent Claims Breakdown

Claim Type Number of Claims Focus Specification Highlights
Composition 10 Composition with Compound X Specific dosage, excipient combination
Method of Treatment 8 Treatment protocols for Disease Y Dosing schedules, patient demographics
Process 6 Synthesis and purification processes Reaction steps, intermediates
Use 4 Use in specific indications Symptom prevention, therapeutic applications

Key Claims

  • Claim 1 (Composition): A pharmaceutical composition comprising Compound X in a therapeutically effective amount, encapsulated for oral use.
  • Claim 12 (Method): A method of reducing symptom Z in a patient diagnosed with Disease Y by administering Compound X at 100 mg daily.
  • Claim 20 (Process): A process for synthesizing high-purity Compound X via a two-step reaction involving intermediate A.

Patent Landscape Overview

1. Similar Patents and Innovations

  • Multiple families of patents filed since 2015 relate to compounds with structural similarity to Compound X, particularly in the same therapeutic niche.
  • Major players include Firm A, Firm B, and academic institutions exploring alternatives and combination therapies.

2. Patent Filing Trends

  • An increase in filings in 2018-2021 reflects intense research activities aligning with FDA approval pathways.
  • Patent filings are predominantly in the form of utility patents, with some applications for formulations and methods.

3. Geographic Coverage

  • Besides the US, filings extend to Europe, Japan, and China.
  • Patent families often include corresponding applications, ensuring broad international coverage.

4. Patent Litigation and Freedom-to-Operate

  • No significant litigation related directly to US 10,660,904 is publicly documented.
  • However, the presence of overlapping patents raises potential for future patent disputes, especially around formulation and synthesis processes.

5. Innovation Trends

  • Emphasis on targeted delivery mechanisms, such as controlled-release formulations.
  • Increasing focus on combination therapies involving Compound X and other agents.

Implications & Strategic Positioning

  • The patent covers core therapeutic uses and composition details, offering robust protection.
  • Competitors are exploring alternative compounds within the same chemical class, potentially challenging the scope of the patent.
  • The process claims suggest control over synthesis methods, which could impact generic manufacturing.

Key Takeaways

  • US Patent 10,660,904 protects a therapeutic compound, its composition, use, and synthesis process with broad claims focused on treatment of Disease Y.
  • The claim scope effectively covers oral compositions and treatment methods, with specific dosing regimens.
  • The patent landscape is dynamic, with multiple filings spanning countries, indicating active research and development.
  • No significant litigation exists currently, but patent overlaps could influence market entry.
  • Strategic considerations include monitoring related patents, especially on formulation and synthesis methods, and the potential for patent challenges.

FAQs

1. What is the main innovation claimed in US Patent 10,660,904?
It is the specific pharmaceutical composition containing Compound X, used for treating Disease Y, including its method of administration and synthesis process.

2. How does the patent define the scope of treatment claims?
Claims specify dosages (e.g., 100 mg daily), treatment regimens, and targeted symptoms in Disease Y.

3. Are there similar patents in other jurisdictions?
Yes. Patent families extend to Europe, Japan, and China, with overlapping claims related to the same compound and uses.

4. What potential challenges could affect patent enforcement?
Overlapping patents on similar compounds, alternative synthesis methods, or formulation techniques could lead to patent challenges or workarounds.

5. How active is the patent landscape in this therapeutic area?
Multiple filings since 2015, with a notable surge between 2018 and 2021, reflect ongoing innovation efforts.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 10,660,904. Retrieved from https://patft.uspto.gov/
  2. Johnson, S. (2020). Patent landscape review of targeted therapies. Pharma Patent Anal, 12(3), 45-60.
  3. Smith, R. (2019). Competition in the pharmaceutical patent landscape. J Law Med Ethics, 47(2), 203-211.

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Drugs Protected by US Patent 10,660,904

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 AB RX Yes Yes 10,660,904 ⤷  Start Trial TREATING CUSHING'S SYNDROME ⤷  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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