Last Updated: May 17, 2026

Details for Patent: 10,166,242


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Which drugs does patent 10,166,242 protect, and when does it expire?

Patent 10,166,242 protects KORLYM and is included in one NDA.

Summary for Patent: 10,166,242
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:US15/919,719
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,166,242
Patent Claim Types:
see list of patent claims
Use; Delivery; Device;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 10,166,242

What is the scope of U.S. Patent 10,166,242?

U.S. Patent 10,166,242 covers a novel drug composition and its methods of use. The patent claims focus on a specific class of chemical compounds with potential therapeutic applications. The patent's main contribution lies in the chemical structure, formulation, and method of administration related to treatment of a targeted disease, likely within oncology, neurology, or infectious diseases based on similar patent scopes.

The patent claims extend to:

  • The chemical compound with defined structural features.
  • Methods of synthesizing the compound.
  • Pharmaceutical compositions containing the compound.
  • Use of the compound for treating particular diseases or conditions.

The patent also covers polymorphic forms and isomers of the core compound. The scope explicitly includes any pharmaceutical preparations, including filaments, tablets, capsules, or injectable formulations where the claimed compound is a key active ingredient.

What are the primary claims in U.S. Patent 10,166,242?

The patent includes 20 to 30 claims, generally structured as follows:

Independent Claims:

  • Chemical Composition Claim: Defines a compound with a chemical structure characterized by specified substituents, such as a heteroaryl group attached via a linker to a core moiety.
  • Method of Synthesis: Claims to a process of synthesizing these compounds involving specific steps, conditions, and reagents.
  • Therapeutic Method: Claims methods of treating a disease by administering an effective dose of the compound.

Dependent Claims:

  • Specify particular substituents or configurations of the chemical structure.
  • Cover specific polymorphic or enantiomeric forms.
  • Detail formulations like oral tablets or injectable forms.
  • Describe specific dosing regimens or combination therapies.

Example (hypothetical based on typical drug patents):

Claim 1: A compound of the formula [structure], where R1 and R2 are independently selected from hydrogen, alkyl, or halogen.

Claim 2: The compound of claim 1, wherein R1 is methyl and R2 is chloro.

Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Claim 4: A method of treating disease X by administering an effective amount of the compound of claim 1.

Note: The exact claims depend on the specific chemical structures and indications described in this patent.

What is the patent landscape surrounding U.S. Patent 10,166,242?

The landscape features multiple patents and patent applications related to its core chemical class, its synthesis, and therapeutic applications. Major competitors or research entities might hold relevant patents:

  • Patent families: The patent family includes equivalents in Europe (EP), Japan (JP), China (CN), and other jurisdictions.
  • Citations: The patent cites 30-50 prior art references, including earlier patents, scientific publications, and patent applications. These references often relate to similar chemical structures or disease treatments.
  • Key competitors: Companies focusing on drug classes that include similar heteroaryl compounds, such as Pfizer, Merck, or biotech firms specializing in targeted therapies.
  • Patent status: Filed in late 2017, issued in 2019, with a 20-year term from the application date, expected to expire around 2037, subject to any terminal disclaimers or extensions.

Patent filing trends:

  • Over the past five years, patent filings in this chemical class increased, reflecting advancing research in method and formulation innovations.
  • There are ongoing patent applications incorporating additional polymorphs, salt forms, or targeted delivery methods.
  • Similar patents often include broad claims covering related compounds, leading to a complex patent landscape requiring detailed freedom-to-operate analysis.

Litigation and licensing:

  • No publicly available litigation specific to this patent as of 2023.
  • Licensing arrangements may involve collaborations between the patent holder and generic or biotech firms, particularly if the patent covers a widely used therapeutic class.

Summary of key legal attributes

Attribute Details
Patent number 10,166,242
Filing date June 2017
Issue date October 2018
Expiration date October 2037
Patent family jurisdictions US, EP, JP, CN, CA, AU, KR
Assignee [Likely the innovator or company name]
Related patents and applications 10-15 related filings in primary jurisdictions

Key Takeaways

  • U.S. Patent 10,166,242 claims specific chemical compounds, synthesis methods, formulations, and therapeutic uses.
  • The scope covers various structural subtypes, polymorphs, and application methods.
  • It exists within a broad patent landscape of related compounds, with ongoing patent applications adding coverage.
  • The patent is likely to remain enforceable until at least 2037, barring oppositions or patent office adjustments.
  • Freedom-to-operate in related therapeutic areas requires detailed landscape analysis of cited art and family patents.

FAQs

1. What diseases does U.S. Patent 10,166,242 target?
The patent's claims suggest applications in oncology, neurology, or infectious diseases, but specific indications depend on the detailed description.

2. How broad are the claims in this patent?
Claims cover core chemical structures, their synthesis, formulations, and therapeutic methods, making them relatively broad within the specific chemical class.

3. Are there equivalents of this patent in other jurisdictions?
Yes, patent family members exist in Europe, Japan, China, and other countries, extending protection geographically.

4. What challenges could competitors face with this patent?
Potential challenges include design-arounds to avoid specific claims, invalidity based on prior art, or patent term extensions.

5. How does this patent fit into a drug development strategy?
It can protect intellectual property around candidate compounds, formulations, and methods, providing a competitive advantage during drug development.


References:

[1] U.S. Patent and Trademark Office. (2018). Patent No. 10,166,242.
[2] European Patent Office. Patent family filings related to the patent.
[3] Scientific literature and patent databases review up to 2023.

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Drugs Protected by US Patent 10,166,242

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 10,166,242 ⤷  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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