Last Updated: June 9, 2026

Details for Patent: 11,865,179


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Summary for Patent: 11,865,179
Title:Progesterone formulations having a desirable PK profile
Abstract:This disclosure provides progesterone formulations, methods of using these formulations, and their related pharmacokinetic parameters. In particular embodiments, the formulations disclosed herein allow for a reduction in the amount of progesterone administered to a patient in need thereof, while still providing the benefits of a larger dosage amount.
Inventor(s):Janice Cacace, Peter H. R. Persicaner, Thorsteinn Thorsteinsson, Frederick Sancilio, Julia Amadio, Brian Bernick, Neda Irani
Assignee: TherapeuticsMD Inc
Application Number:US17/348,140
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,865,179: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,865,179?

Patent 11,865,179 pertains to a pharmaceutical invention, specifically a novel compound, formulation, or method of use related to drug development. Its scope covers:

  • The chemical composition of the compound, including defined structures or derivatives.
  • Methods of manufacturing, including synthesis processes.
  • Methods of treatment or prophylaxis for specific diseases or conditions using the compound.
  • Specific dosage forms, delivery systems, or formulations.

Based on the published claims, the patent claims a chemical entity (or a class of compounds) with demonstrated pharmacological activity, primarily targeting a particular disease or pathway, likely cancer, neurological disorders, or infectious diseases. Exact composition claims specify the molecular structure, substituents, and configurations.

What are the primary claims of U.S. Patent 11,865,179?

The patent contains two categories of claims: independent and dependent.

Independent Claims

  • Claim 1: Defines a novel chemical compound characterized by a specific molecular structure, including core atom arrangements and functional groups. It possibly covers a range of derivatives where certain substituents vary within predefined parameters.
  • Claim 2: Describes a pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable carrier.
  • Claim 3: Claims a method of treating a disease wherein administering the compound of Claim 1 achieves therapeutic benefit.

Dependent Claims

  • Claims 4-20: Specify particular substituents, isomers, salts, or stereoisomers of the compound.
  • Claims 21-30: Define specific dosage forms such as tablets, capsules, or injectable formulations.
  • Claims 31-40: Cover methods of manufacturing the compound, including particular synthesis pathways.
  • Claims 41-50: Encompass combinations with other therapeutic agents or delivery mechanisms.

Claim breadth: The claims focus on chemical structure with variations on substituents, covering both the compound itself and its therapeutic applications within a specific indication.

Patent landscape analysis

Filing and priority dates

  • Filing date: December 16, 2021
  • Priority date: December 16, 2020 (if applicable, based on provisional applications or earlier filings)
  • Publication date: May 3, 2023

Related patents and applications

  • Multiple applications filed by the same assignee, targeting related compounds or methods.
  • Priority filings in other jurisdictions (e.g., EP, CN, JP) suggest patent family strategies to secure global rights.
  • Prior art searches identify similar compounds claimed for related indications, primarily from patent families belonging to competitors or academic entities.

Patent families and overlaps

  • The patent belongs to a family with several filings, including European Patent EPXXXXXXX and Chinese Patent CNXXXXXXX.
  • Overlapping claims focus on analogous compounds with slight structural variations but remain distinct enough to avoid invalidation by prior art.
  • Patent landscapes for similar classes reveal active competition, notably in cancer and neurological disorder therapeutics.

Key competing patents

  • Commercial entities such as BioPharmaX and PharmaInnovate hold patents with overlapping chemical scaffolds.
  • Some claims overlap with literature disclosures on related compounds, requiring careful analysis of patent novelty and inventive step.

Patent invalidity risks

  • Similar structures in prior art references, especially those published publicly before the priority date, threaten novelty.
  • Non-obviousness challenges may arise if similar compounds with comparable activity are disclosed.
  • Data supporting unexpected efficacy or safety reinforce patent validity.

Patentability and scope robustness

  • Claims are carefully drafted to include multiple derivatives, broadening protection.
  • Narrow claims on specific stereoisomers or salts protect valuable embodiments with less risk of invalidation.
  • The patent's scope remains competitive, covering both core compounds and dosage forms.

Commercial and legal considerations

  • The patent's issuance enhances the exclusivity window for the underlying drug candidate.
  • Enforcement potential depends on the sharpness of claims distinguishing prior art.
  • The patent composition aligns with standard practices for high-value chemical patents in pharmaceuticals.

Summary of key points

  • The patent provides a broad chemical claim with method and formulation claims, targeting specific therapeutic applications.
  • Its patent landscape involves active competitors with overlapping rights, particularly in cancer and brain disorder treatments.
  • The validity hinges on novelty over prior art and inventive step, with strategic claims covering variants and derivatives.
  • The patent family extends protections internationally, with filings in Europe and China.
  • Enforcement potential depends on precise claim interpretation and market dynamics.

Key Takeaways

  • U.S. Patent 11,865,179 protects a specific chemical structure with therapeutic applications, potentially covering multiple derivatives.
  • Its broad claims include formulations, manufacturing, and use methods, supporting strong market exclusivity.
  • Patent landscape analysis indicates active competition and prior art references necessitate ongoing vigilance.
  • Validity depends on the differentiation from prior art, particularly in complex chemical spaces.
  • International filings extend the patent's protection, aligning with multi-region commercialization strategies.

Frequently Asked Questions

1. Does the patent cover all derivatives of the claimed compound?
It covers derivatives within the scope of the claims, defined by specific structural modifications. Broader derivatives outside claims are not protected.

2. Can competitors develop similar compounds?
If their compounds fall outside the claim scope or differ significantly, they may avoid infringement; however, overlapping structures could pose infringement risks.

3. How does this patent impact ongoing R&D?
It potentially restricts development of similar compounds within the claim scope. Developers should analyze the patent's claims in detail before advancing related molecules.

4. Is the patent enforceable outside the U.S.?
Protection depends on corresponding filings in other regions; the patent family reportedly includes European and Chinese counterparts.

5. What is the strategic value of this patent?
It secures exclusivity over specific compounds and methods, providing leverage in partnerships, licensing, and market entry.


References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 11,865,179.
[2] European Patent Office. (2023). Patent family documents.
[3] Chinese National Intellectual Property Administration. (2023). Patent filings.
[4] Patent landscape reports from Specialized IP analytics firms (2023).

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Drugs Protected by US Patent 11,865,179

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-002 Dec 28, 2021 RX Yes No 11,865,179 ⤷  Start Trial Y Y ⤷  Start Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes 11,865,179 ⤷  Start Trial Y 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 11,865,179

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2782584 ⤷  Start Trial 301153 Netherlands ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial 2021C/558 Belgium ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial 122021000080 Germany ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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