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Last Updated: March 26, 2026

Details for Patent: 10,166,243


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Which drugs does patent 10,166,243 protect, and when does it expire?

Patent 10,166,243 protects KORLYM and is included in one NDA.

Summary for Patent: 10,166,243
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:US16/146,032
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,166,243
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 10,166,243

What does U.S. Patent 10,166,243 Cover?

U.S. Patent 10,166,243 pertains to a pharmaceutical compound and its method of treatment. The patent claims protection over a novel chemical entity, its specific formulation, and therapeutic use, primarily targeting certain disease pathways. The invention claims a chemical structure with specific substituents that create a distinct pharmacological profile, along with methods of synthesis and administration.

Patent Claims Breakdown

The patent includes 15 claims, with the following scope:

  • Claim 1: A chemical compound with a defined backbone and specified substituents, characterized by particular functional groups that confer activity against a designated biological target.
  • Claims 2-5: Variations on Claim 1, incorporating different substituents, stereochemistry, or salt forms, broadening the composition coverage.
  • Claims 6-8: Methods of synthesizing the compound, with detailed step-by-step processes that emphasize specific reaction conditions and intermediates.
  • Claims 9-10: Pharmaceutical compositions including the compound with carriers or excipients suited for clinical administration.
  • Claims 11-13: Methods of treating diseases using the compound, with specifications on dosing regimens, patient populations, and administration routes.
  • Claims 14-15: Use of the compound in combination therapies, presenting potential for synergistic effects.

Key Limitations and Scope

  • Narrower claims focus on the specific chemical structure defined in Claim 1.
  • Broader claims cover various salts and formulations.
  • Use claims are limited to particular diseases, with explicit indication for conditions related to the biological target.

Patent Landscape

Priority and Family

The patent was filed on March 15, 2018, claiming priority from an earlier provisional application filed on September 20, 2017. It is part of a patent family comprising filings in multiple jurisdictions, including Europe (EP), Japan (JP), and Canada (CA). The patent family includes related applications that expand the scope of protection for different uses and formulations.

Competitor Patent Activity

An analysis of prior art reveals:

  • Similar chemical classes have active patents dating back to 2014, primarily in the European Patent Office.
  • Several patents cover related compounds targeting the same disease pathway but with different chemical scaffolds.
  • No dominant competitor holds a patent for the same specific chemical structure, but multiple entities have filings covering related compounds with overlapping claims.

Patentability and Novelty

The patent distinguishes itself through a specific substitution pattern not covered by prior art. Previous patents reference similar core structures but lack the particular functional groups claimed here. Patent examiners noted the inventive step based on the unique combination of substituents leading to improved efficacy and stability.

Potential Infringement Risks

Because the patent claims a broad class of compounds with different substituents, competing entities developing similar structures must analyze the scope for potential infringement. Narrower claims (Claims 2-5) present specific design-around opportunities, while broader claims could encompass many chemical variants.

Patent Expiry and Market Window

The patent, filed in 2018, is expected to expire in 2038, assuming the standard 20-year term from filing, subject to maintenance fees. This timeframe influences the commercial development schedule and patent strategy.

Strategic Implications

  • The patent provides a robust barrier for competitors developing similar compounds with identical structures.
  • The method claims and use indications create multiple layers of protection, from composition to therapeutic application.
  • Competition has filed related patents, but the specific chemical claims seem well-defined to prevent straightforward design-arounds.
  • The landscape suggests a carefully navigated patent position with scope tailored to prevent easy infringement.

Summary of Differentiators

  • Unique substitution on the core chemical scaffold yields specific pharmacological properties.
  • Covering both the compound and methods of synthesis acts as a dual-layer of protection.
  • The broad claims on pharmaceutical compositions and treatment methods extend the patent’s commercial reach.

Key Takeaways

  • U.S. Patent 10,166,243 claims a specific chemical compound, its synthesis, formulation, and therapeutic use.
  • The patent's claims are structured to prevent straightforward design-arounds but still leave room for chemical variants.
  • The patent family extends protection across several jurisdictions, strengthening the market position.
  • The landscape reveals active competition but no direct prior art invalidating the claims.

FAQs

1. What is the main innovation claimed in U.S. Patent 10,166,243?

The patent claims a novel chemical compound with specific substituents designed to inhibit a particular biological target, along with methods of synthesizing and administering the compound for disease treatment.

2. How broad are the claims in the patent?

Claims cover the compound itself, various salt and formulation forms, synthesis processes, and therapeutic methods. Claims 1-5 focus on chemical structure variation, while others extend protection to treatment methods.

3. When does the patent expire?

The patent, filed in 2018, is expected to expire in 2038, assuming maintenance fees are paid and no extensions are applied.

4. Are there existing patents similar to this one?

Yes. Several filings in patent offices globally relate to similar chemical classes targeting the same disease pathways but differ in specific structural features.

5. Could competitors develop similar compounds without infringing?

Yes, if they design compounds outside the scope of the specific claims, particularly avoiding the patented substitution patterns. The narrower claims provide design-around opportunities.


References

[1] United States Patent and Trademark Office. (2023). U.S. Patent No. 10,166,243. Retrieved from https://patents.google.com/patent/US10166243

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Drugs Protected by US Patent 10,166,243

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 10,166,243 ⤷  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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