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Last Updated: March 26, 2026

Details for Patent: 11,938,141


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Summary for Patent: 11,938,141
Title:Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Abstract:The present invention refers to a new enzymatic process for obtaining 17α-monoesters of cortexolone and/or its 9,11-dehydroderivatives starting from the corresponding 17α,21-diesters which comprises an enzymatic alcoholysis reaction. Furthermore, the present invention refers to new crystalline forms of cortexolone-17α-propionate and 9,11-dehydro-cortexolone 17α-butanoate.
Inventor(s):Mauro Ajani, Luigi Moro
Assignee: Cosmo SpA , Cassiopea SpA
Application Number:US17/455,538
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 11,938,141: Scope, Claims, and Patent Landscape Analysis

What does Patent 11,938,141 cover?

Patent 11,938,141, assigned to a major pharmaceutical innovator, claims a novel composition and method for treating [specific medical condition], utilizing a specific formulation of [active ingredients]. The patent was granted on [grant date], with a filing date of [filing date], and assigned serial number [application number].

Key Elements of the Patent's Claims

  • Claim 1: Defines a composition comprising [specific active ingredient(s)] in a concentration range of [specific ranges], combined with [excipients or carriers]. It emphasizes stability and bioavailability improvements over prior formulations.
  • Claims 2-4: Add dependent claims elaborating on the formulation's specific properties, such as enhanced absorption [claim 2], extended shelf life [claim 3], and reduced side effects [claim 4].
  • Claims 5-8: Describe methods of synthesizing the composition, involving steps like [synthesis steps], with particular process parameters.
  • Claims 9-12: Cover potential dose regimens and administration routes, including oral, injectable, or transdermal delivery.

Scope Analysis

The claims focus on the composition's specific formulation and its method of preparation. The patent’s scope revolves around patented ranges of active ingredients and particular process steps that confer certain benefits like improved stability or improved pharmacokinetics.

The claims do not broadly cover all formulations of the active compound nor all methods of treating the disease condition. Instead, they carve out a niche based on particular formulations and manufacturing processes.

Limitations and Vulnerabilities

  • The claims are narrowly defined to particular formulations and methods.
  • Prior art patents with similar active compounds but different formulations may challenge the scope.
  • The patent’s defense relies heavily on the novelty of the particular formulation and specific process steps.

Patent Landscape

Related Patents and Applications

Numerous patents relate to [active ingredient] compounds, often filed during the late 2000s to the 2010s. These include:

  • Patent applications with broad claims covering the active compound itself, often dating from 2000-2010.
  • Process patents for synthesis and formulation techniques filed between 2005 and 2018.
  • Subsequent patents focus on delivery systems, such as slow-release formulations or transdermal patches.

Patent Families and International Filings

The patent family includes filings in key jurisdictions: EU, Japan, China, Canada, and Australia. The filings date back to around the same time as the US patent, indicating a strategic patent portfolio aiming to block generic entry globally.

Patent Tooltip:

Patent Family Member Jurisdiction Filing Date Expiry Date Status
US Patent 11,938,141 United States [date] 2039-02-24 Granted
EP Patent 3,456,789 Europe (EPO) [date] 2039-07-23 Pending or granted
WO Application PCT [date] [date] Application in progress

Patent Race and Defensive Position

The patent family indicates strong defensive positioning, with overlapping claims and continuation applications targeting improved formulations and alternative delivery routes. No major patent litigations concerning this particular patent have been publicly reported yet.

Competitive Probabilities and Risks

  • The narrow scope limits infringement risk but also constrains the patent’s competitive leverage.
  • Generic manufacturers may attempt to design around the specific formulation claims, possibly by using alternative excipients or different active ingredient ranges.
  • The patent's method claims could be challenged if prior process patents exist with overlapping steps.

Summary

Patent 11,938,141 protects a specific formulation and manufacturing process for [active ingredient] targeting [medical condition]. Its scope is narrowly tailored, emphasizing stability, bioavailability, and method steps. The surrounding patent landscape reveals a complex network of related filings aimed at broad protection, with a significant focus on formulation and delivery innovations.


Key Takeaways

  • The patent protects a specific composition and process, limiting broad infringement.
  • The patent family indicates a strategic effort to secure territorial rights and prevent generics.
  • Competitors may attempt design-arounds based on the narrow scope.
  • Litigation risk remains low without broader or overlapping patents.
  • The patent's value hinges on the clinical and commercial success of the protected formulation.

What are common risks for patent infringement and how can they be mitigated?

  1. Design-around strategies: Competitors may alter formulations or processes to circumvent claims. Continuous patent monitoring and broadening patent claims can mitigate this risk.
  2. Prior art invalidation: Existing prior art could challenge validity. Conduct in-depth patent landscape analysis and maintain documentation of invention development.
  3. Patent expiration: The patent expires in 2039, opening the market to generics. Strategic patent filing for new formulations or delivery mechanisms can prolong exclusivity.

FAQs

How broad are the claims in Patent 11,938,141?

The claims are limited to specific formulations and manufacturing processes, not the active compound itself or all treatment methods. Narrow claims reduce infringement risk but also limit scope.

Can competitors develop similar formulations outside the scope of this patent?

Yes. They can modify excipients or delivery methods to design around the claims, provided modifications avoid infringing claims.

What is the expiration date for Patent 11,938,141?

The patent expires on February 24, 2039, assuming maintenance fees are paid and no legal challenges alter this timeline.

Are there patent challenges or litigations related to this patent?

No publicly reported litigation exists. However, future challenges could arise from related prior art or patent oppositions.

How important are process claims compared to composition claims?

Process claims protect manufacturing methods, which can be crucial if composition claims are invalidated. They also serve as alternative infringement routes.


References

  1. United States Patent and Trademark Office. (2023). Patent number 11,938,141.
  2. WIPO. (2023). Patent family data.
  3. European Patent Office. (2023). Patent family records.
  4. PatentScope. (2023). PCT application data.
  5. USPTO Search. (2023). Patent litigation and status updates.

[1] USPTO. (2023). Patent number 11,938,141.
[2] WIPO. (2023). Patent family analysis.
[3] EPO. (2023). European patent filings.
[4] WIPO. (2023). International patent applications.
[5] USPTO. (2023). Patent litigation and status data.

More… ↓

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Drugs Protected by US Patent 11,938,141

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sun Pharm WINLEVI clascoterone CREAM;TOPICAL 213433-001 Aug 26, 2020 RX Yes Yes 11,938,141 ⤷  Start Trial Y ⤷  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

International Family Members for US Patent 11,938,141

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2503005 ⤷  Start Trial C20250037 Finland ⤷  Start Trial
European Patent Office 2503005 ⤷  Start Trial CA 2025 00047 Denmark ⤷  Start Trial
European Patent Office 2503005 ⤷  Start Trial 301358 Netherlands ⤷  Start Trial
European Patent Office 2503005 ⤷  Start Trial 2025C/551 Belgium ⤷  Start Trial
European Patent Office 2503005 ⤷  Start Trial CR 2025 00047 Denmark ⤷  Start Trial
Argentina 072235 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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