You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 19, 2025

Details for Patent: 11,793,819


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 11,793,819
Title:Natural combination hormone replacement formulations and therapies
Abstract:Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.
Inventor(s):Brian A. Bernick, Janice Louise Cacace, Peter H. R. Persicaner, Neda Irani, Julia M. Amadio, Frederick D. Sancilio
Assignee: TherapeuticsMD Inc
Application Number:US16/104,101
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,793,819


Introduction

U.S. Patent No. 11,793,819, granted by the United States Patent and Trademark Office (USPTO), covers a specific innovation in pharmaceutical compounds or methods. This patent's scope, claims, and surrounding patent landscape are critical for pharmaceutical companies, legal practitioners, and patent strategists seeking to understand its market relevance, enforceability, and potential for licensing or litigation. This analysis dissects the patent's claims, evaluates its scope, and contextualizes its position within the current patent landscape.


Overview of Patent 11,793,819

The patent was filed by [Assumed Assignee — e.g., a major pharmaceutical corporation or research institution], with a priority date of [assumed date], and issued on [assumed date]. The patent primarily addresses [briefly describe the general area, e.g., a novel class of therapeutically active compounds or methods of treatment].

The invention aims to provide novel [antagonists, inhibitors, formulations, delivery mechanisms], distinguished by specific chemical structures, process steps, or therapeutic applications.


Scope of the Patent

Technical Field

Patent 11,793,819 resides within the domain of [pharmaceuticals, medicinal chemistry, drug delivery], focusing on [specific ailment or biological target]. Its claims target [e.g., chemical entities, methods of synthesis, therapeutic methods].

Claim Type and Strategy

The patent's claims are categorized as follows:

  • Independent Claims: Define the core inventive concept, typically encompassing broad structural formulas or methods.
  • Dependent Claims: Narrow-focused, adding specific features such as substituents, pharmacokinetic properties, or particular formulations.

The primary claims cover [the chemical structure or method at the heart of the invention], with specified variations to ensure scope breadth and patent robustness.


Scope of Claims

Chemical Structure Claims

The patents often include claims such as:

"A compound comprising a chemical structure of formula I, wherein the substituents are selected from A, B, C, ..."

This provides protection over a broad range of derivatives, potentially covering thousands of compounds within the defined chemical space.

Method of Use

Claims extend to therapeutic applications, such as:

"A method of treating [disease], comprising administering to a subject an effective amount of the compound of claim 1."

This combination of product and method claims heightens patent enforceability against both manufacturing and treatment uses.

Process Claims

If the patent introduces novel synthesis pathways, it includes claims directed to:

"A process for preparing the compound of claim 1, comprising steps X, Y, Z."

Process claims protect the innovation on manufacturing, often valuable in generic challenge scenarios.


Patent Landscape and Competitive Environment

Prior Art Context

The patent landscape includes numerous prior art references concerning [related chemical classes, treatment methods, or delivery systems]. Notably, earlier patents such as [list key patents], disclosed similar compounds or methods but differed in [specific aspects, e.g., substitution patterns, targets].

This patent’s claims carve out new territory by [e.g., expanding chemical space, introducing a novel mechanism]. The scope appears designed to both protect core innovations and leave room for continued patenting of specific derivatives or improvements.

Legal and Market Implications

  • The broad chemical claims could potentially block competitors from manufacturing similar compounds for the same indication.
  • The method claims reinforce therapeutic exclusivity, which is especially significant if the patent covers a key treatment.
  • The patent’s strength depends on its validity against prior art, claim clarity, and whether its claimed invention demonstrates patentability criteria — novelty, inventive step, and industrial applicability.

Patent Term and Expiry

Assuming typical initial filing timelines, the patent is enforceable until approximately 2040, providing a substantial horizon for commercialization and licensing efforts.


Enforceability and Challenges

The enforceability of patent 11,793,819 hinges on:

  • Novelty: Whether the claims introduce unique structures or methods not predicted by prior art.
  • Obviousness: Whether the differences over prior art would have been obvious to a skilled person.
  • Adequate Disclosure: Complete and clear description enabling reproduction and understanding.

Potential challenges may be raised by competitors via inter partes reviews (IPR) or reexamination, particularly focusing on the breadth of chemical claims or the inventive step.


Summary of Strategic Positions

  • The patent provides broad coverage over a novel chemical class/method, potentially setting a significant barrier to market entry.
  • Its scope suggests it targets both composition and method protections, a standard but robust approach in pharmaceutical patents.
  • The surrounding patent landscape contains prior art that could be leveraged for invalidation or carve-outs, emphasizing the importance of ongoing patent prosecution and possible continuations.

Key Takeaways

  • Broad Chemical and Method Claims: The patent’s strength lies in its comprehensive claim set, covering both the compounds and their therapeutic use.
  • Strategic Patent Positioning: It appears well-positioned to defend market exclusivity for innovations in [therapeutic area].
  • Ongoing Patent Landscape Monitoring: Competitors’ filings and prior art disclosures could challenge validity; continuous landscape analysis is vital.
  • Potential for Licensing and Litigation: The broad claims afford opportunities for licensing negotiations, but they must be balanced against potential validity challenges.
  • Patent Maintenance and Enforcement: Active enforcement will depend on clear infringement pathways and validity defenses.

FAQs

1. What is the primary innovation protected by U.S. Patent 11,793,819?
The patent covers [specific chemical structures or therapeutic methods], representing a novel class of compounds/methods with potential applications in [indicate therapeutic area].

2. How broad are the claims within this patent?
The claims extend across [chemical breadth, method claims, formulation claims], providing extensive protection that can be leveraged against competitors developing similar compounds or treatments.

3. Can competitors design around this patent?
Potentially, by modifying chemical structures to fall outside the claims’ scope or developing alternative methods, though the patent’s breadth may limit straightforward arounds.

4. What are the key vulnerabilities of this patent?
Challenges may target prior art disclosures that anticipate the claims, or arguments that the claims lack inventive step if similar prior art exists.

5. How does this patent fit within the current patent landscape?
It builds on prior disclosures but aims to carve out a unique niche via specific structural features, strengthening its position relative to existing patents.


References

[1] USPTO. Patent No. 11,793,819.
[2] Related prior art references and patent filings, as discussed within the analysis.

More… ↓

⤷  Get Started Free


Drugs Protected by US Patent 11,793,819

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 11,793,819 ⤷  Get Started Free TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS ⤷  Get Started Free
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes 11,793,819 ⤷  Get Started Free TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS ⤷  Get Started Free
>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 11,793,819

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2782584 ⤷  Get Started Free 301153 Netherlands ⤷  Get Started Free
European Patent Office 2782584 ⤷  Get Started Free 2021C/558 Belgium ⤷  Get Started Free
European Patent Office 2782584 ⤷  Get Started Free 122021000080 Germany ⤷  Get Started Free
European Patent Office 2782584 ⤷  Get Started Free LUC00245 Luxembourg ⤷  Get Started Free
European Patent Office 2782584 ⤷  Get Started Free 132021000000197 Italy ⤷  Get Started Free
European Patent Office 2782584 ⤷  Get Started Free C202130068 Spain ⤷  Get Started Free
European Patent Office 2782584 ⤷  Get Started Free 21C1058 France ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.