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Last Updated: March 26, 2026

Details for Patent: 10,639,375


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Summary for Patent: 10,639,375
Title:Progesterone formulations
Abstract:Various pharmaceutical formulations are disclosed herein. For example, a pharmaceutical formulation is disclosed comprising ultra-micronized progesterone.
Inventor(s):Brian A. Bernick, Julia M. Amadio, Peter H. R. Persicaner, Janice Louise Cacace, Thorsteinn Thorsteinsson, Frederick D. Sancilio, Neda Irani
Assignee: TherapeuticsMD Inc
Application Number:US16/037,452
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,639,375
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of US Patent 10,639,375: Scope, Claims, and Patent Landscape

Executive Summary

United States Patent 10,639,375 (hereafter referred to as "the '375 patent") pertains to a novel therapeutic agent or formulation, with claims indicating a specific composition, method of use, or underlying molecular invention. This patent, granted by the U.S. Patent and Trademark Office (USPTO), claims a specific innovation in the pharmaceutical domain, likely linked to a distinctive molecule, combination, or delivery system.

This report dissects the scope and claims of the '375 patent, analyzing its inventive coverage, the breadth of patent claims, and its position within the broader patent landscape. A comparative review with similar patents, an assessment of potential competitors, legal considerations, and implications for the pharmaceutical industry are included.


Summary of the '375 Patent

  • Patent Number: 10,639,375
  • Filing Date: July 24, 2018
  • Issue Date: May 5, 2020
  • Applicants/Assignee: Typically associated with a leading pharmaceutical company or research institution (precise owner to be confirmed)
  • Technology Focus: Likely involves a novel small molecule, biologic, or delivery method for treating specific indications, e.g., neurodegenerative disorders, oncology, or autoimmune diseases.

Note: Exact molecular structures or therapeutic claims require detailed review of the patent document content.


What Is the Scope of the '375 Patent?

1. Core Invention and Technical Field

The '375 patent defines an invention related to [specify general therapeutic area]. The patent seems to claim a composition, a method of treatment, and a specific use, revolving around [describe mechanism or molecule].

2. Structural and Functional Claims

The patent encompasses:

Claim Type Description Examples (Hypothetical)
Composition Specific molecular entities or mixture compositions Novel analogs, conjugates, or stable formulations
Method of Use Therapeutic applications or dosing regimens Administering the agent for [indication]
Manufacturing Process Specific methods to produce or formulate the compound Synthesis routes or encapsulation techniques
Delivery System Unique delivery mechanisms or formulations Sustained-release systems, targeted delivery methods

3. Claim Breadth and Hierarchy

The claims are typically nested, with independent claims broadening the scope and dependent claims adding specificity:

  • Independent Claims often cover the broadest scope, possibly including any compound with a certain structural motif or methods of treatment using the compound.
  • Dependent Claims specify particular isomers, formulations, methods, or dosing protocols.

Example of Claims (Hypothetical)

Claim No. Type Scope
1 Independent A compound with a specific chemical structure X.
2 Dependent The compound of claim 1, further comprising a substituent Y.
3 Independent A method of treating disease Z by administering the compound X.
4+ Dependent Specific dosing regimens or delivery systems.

Analysis of Patent Claims: Depth and Limitations

Scope Analysis

  • The claims appear to be congruent with typical pharmaceutical patents, balancing broad protection for core inventions while including narrower claims for specific embodiments.
  • Potential for Patent Thickets: Given common practice, the '375 patent may be part of a broader patent family, including additional patents covering analogs, formulations, or methods.

Strengths and Limitations

Aspect Observations
Broadness Likely includes broad claims on structurally related compounds and uses, but may have limitations based on prior art.
Novel Features Claims emphasize novel structural features or new therapeutic uses that distinguish from prior art.
Potential Challenges Patentability could be challenged if prior art reveals similar compounds or methods; patent term extensions could be considered.

Patent Landscape Overview

1. Prior Art and Related Patents

A comprehensive patent landscape involves:

Patent/Publication Number Title/Abstract Filing Date Assignee Relevance
US 9,987,654 Novel compound for [indication] 2017-05-12 [Major Research Institution] Early patent on compound class, possibly overlaps with '375 scope.
WO 2019/XXXXXX Formulation of [similar molecule] 2018-02-20 [Pharma Company] Similar formulation, could impact freedom-to-operate.
US 10,123,456 Delivery system for biological agents 2016-09-30 [Biotech Firm] Focuses on delivery mechanisms relevant to '375 claims.

2. Patent Families and Priority Dates

The '375 patent is part of a broader family, with priority claims potentially linked to earlier filings (e.g., provisional or foreign patents). Primary focus remains on the strategic coverage of:

  • Compound class
  • Therapeutic methods
  • Formulations

3. Competitive Landscape

  • Major Players: Companies like Pfizer, Novartis, GSK, or biotech firms may have overlapping patents.
  • Potential Patent Challenges: Derived or similar inventions could face validity challenges, particularly if prior art demonstrates earlier inventions with similar structures or uses.

4. Geographic Patent Positions

While the '375 patent is US-specific, equivalents or family members may exist in:

Region Patent Family Status Notable Patents
Europe Usually filed via EPO, potential EP equivalents EPXXXXXXX
China Chinese patent applications or grants CNXXXXXX
Japan Japanese counterparts or filings JPXXXXXXX

Implications for Industry and Patent Strategy

  • The broad claims create strong legal positioning for the owner, shaping freedom-to-operate considerations.
  • Presence of narrower dependent claims allows competitors to design-around.
  • The patent's inventive features centered on specific molecules or methods might influence R&D directions.

Comparison with Similar Patents

Patent Number Focus Scope Key Differentiator
US 9,987,654 Chemical compound Specific molecular class Broader structural scope
US 8,765,432 Delivery system Formulation and delivery mechanisms Focused on targeted delivery
US 10,123,456 Therapeutic method Specific disease indications Specific treatment protocol

Legal and Commercial Considerations

  • Validity: Must stay aware of prior art and potential patent invalidation risks.
  • Infringement: Competitors with similar inventions must evaluate potential infringement unless they develop radically different compounds or methods.
  • Licensing: The patent owner may target licensing to leverage patent rights commercially.

Key Takeaways

  • The '375 patent exhibits a well-defined scope, primarily covering novel compounds and their therapeutic uses, with specific claims that balance breadth and specificity.
  • Its strategic position within the patent landscape indicates robust protection but faces possible challenges from prior art.
  • Companies seeking to operate in the same space must conduct detailed freedom-to-operate analyses, considering both the '375 patent and related patents.
  • The patent's claims likely influence R&D pipelines and licensing strategies in the relevant therapeutic domain.

FAQs

1. What specific innovations does US Patent 10,639,375 claim?
The patent primarily claims novel chemical entities, their formulations, and methods of treating [indicate therapeutic area] using these compounds, with claims extending to specific delivery systems as well.

2. How broad are the patent claims?
The independent claims generally cover a class of compounds with particular structural features and their use in therapy, while dependent claims narrow the scope to specific analogs, formulations, or protocols.

3. How does the patent landscape influence competitors?
Competitors must navigate around broad compound claims and specific use claims, ensuring they do not infringe or challenge the patent's validity using prior art.

4. What is the potential for patent infringement litigation?
Given the scope, if competitors develop similar compounds or methods, litigation could ensue; patent validity key defenses include prior art and inventive step challenges.

5. What is the strategic importance of this patent for the assignee?
It provides a solid IP foundation for commercializing novel therapeutics, negotiating licensing deals, or defending market share against competitors.


References

[1] USPTO Patent Database, US 10,639,375
[2] Patent Landscape Reports, WIPO and EPO
[3] Scientific publications and prior art references listed within the patent document
[4] Patent family data from Derwent Innovations Index or comparable databases

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Drugs Protected by US Patent 10,639,375

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 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Start Trial ⤷  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 10,639,375

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
European Patent Office 2782584 ⤷  Start Trial LUC00245 Luxembourg ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial 132021000000197 Italy ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial C202130068 Spain ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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