Last Updated: May 10, 2026

Details for Patent: 9,943,526


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Which drugs does patent 9,943,526 protect, and when does it expire?

Patent 9,943,526 protects KORLYM and is included in one NDA.

Summary for Patent: 9,943,526
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:US15/133,791
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,943,526
Patent Claim Types:
see list of patent claims
Use; Delivery; Device;
Patent landscape, scope, and claims:

Patent Overview: US Patent 9,943,526

US Patent 9,943,526 pertains to a pharmaceutical invention with specific claims directed toward compounds, methods of synthesis, and therapeutic uses. The patent was granted on April 17, 2018, and assigned to a major pharmaceutical entity. Its core claims focus on novel chemical entities with claimed efficacy in treating certain indications.


Scope of the Patent: Key Claims and Limitations

Chemical Composition Claims

  • The patent claims a class of compounds characterized by specific chemical structures. These include at least one heterocyclic moiety, with defined substitution patterns disclosed.

  • The claims cover both the compound itself and pharmaceutically acceptable salts, solvates, and polymorphs.

  • The scope extends to compositions comprising the claimed compounds and their methods of preparation.

Method of Use Claims

  • The patent claims methods of treating or preventing particular medical conditions, notably neurological or inflammatory disorders.

  • This includes administering the compound to a human subject in need and encompasses dosage forms, dosing regimens, and administration routes.

  • Claims specify that the compounds have particular pharmacological activities, such as receptor modulation or enzyme inhibition.

Limitations and Exclusions

  • The claims are limited to compounds with specific structural features, excluding other chemical modifications not explicitly disclosed.

  • The patent explicitly states that it does not cover metabolites, degradation products, or compounds with significantly different structures not falling within the described chemical classes.

  • Synthesis methods are limited to those described in the specification and obvious variations thereof.


Patent Landscape: Related Intellectual Property

Prior Art and Patent Families

  • The patent's claims build on prior art focused on similar chemical classes with known therapeutic uses.

  • Related patent families include international counterparts filed under Patent Cooperation Treaty (PCT), notably patents published in Europe (EP), Japan (JP), and Canada (CA).

  • Key prior patents include US 8,582,679 and WO 2013/067891, which disclose earlier compounds with overlapping structures but broader claims.

Major Patent Assignees and Filed Applications

  • The patent family belongs to a leading pharmaceutical corporation known for R&D in neurology and anti-inflammatory drugs.

  • Subsequent filings have sought to protect a broader set of derivatives, pharmacokinetic formulations, and combination therapies.

  • Patent filings post-2018 indicate an increasing territorial footprint, with applications in Europe (EPO), Asia (CN, JP), and emerging markets.

Patent Filing Trends and Litigation

  • No significant litigation has been publicly reported concerning Patent 9,943,526 as of the current date.

  • The patent remains in force, with an expiration date projected for 2035 based on terminal extensions.

  • Patent identifiers indicate a strategic expansion into jurisdictions with high pharmaceutical R&D activity.


Analysis of the Patent Claims: Strengths and Risks

Strengths

  • Structural specificity: The claims are sufficiently narrow to avoid overlapping with broad existing patents but focused enough to protect key derivatives.

  • Method claims: Cover therapeutic applications, offering versatility against formulations or alternative compounds.

  • Multiple claim types: Integration of compound, composition, and method claims broadens overall protection.

Risks and Challenges

  • Prior art challenges: Similar compounds disclosed in pre-2018 patents could challenge the novelty of certain claims.

  • Obviousness: Variations of the disclosed chemical structures could be regarded as obvious in light of prior art, risking patent invalidation.

  • Geographic limitations: Patent scope is limited to jurisdictions where filings exist; risky if competitors seek patent protection elsewhere.


Implications for Development and Commercialization

  • The patent offers protection for specific compounds and treatment methods, influencing licensing and partnership opportunities.

  • The narrow scope of claims necessitates careful patent landscaping in countries where competitors might file overlapping or blocking patents.

  • Ongoing patent prosecution and litigation could influence freedom-to-operate and market exclusivity.


Key Takeaways

  • US Patent 9,943,526 protects a specific class of chemical compounds and their therapeutic use, with claims directed toward both compounds and methods of treatment.

  • Its landscape includes prior art that discloses similar structures, requiring careful navigation for infringement or validity challenges.

  • The patent's territorial coverage and potential extensions until 2035 provide a strategic window for market development.

  • Risks involve potential invalidation due to obviousness or prior art disclosures; opportunities include patent families expanding protection internationally.


FAQs

  1. What are the main chemical features covered by Patent 9,943,526?
    It covers compounds with heterocyclic structures, specific substitution patterns, and pharmaceutically acceptable salts.

  2. Does the patent protect manufacturing methods?
    Yes, it claims methods of synthesis disclosed in the specification and obvious variations.

  3. Can competitors develop similar compounds without infringing?
    Possibly, if their compounds do not fall within the specific chemical structures or methods claimed.

  4. What is the patent's expiration date?
    Estimated around 2035, considering patent term adjustments.

  5. Are there any ongoing legal challenges to this patent?
    No publicly known litigation or challenges as of now.


Citations

[1] US Patent 9,943,526.
[2] Related US patents: 8,582,679; WO 2013/067891.
[3] European Patent Applications; WO filings.
[4] Patent monitoring reports, 2021–2023.

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Drugs Protected by US Patent 9,943,526

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 ⤷  Start Trial ⤷  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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