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Last Updated: December 12, 2025

Details for Patent: 10,675,288


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Summary for Patent: 10,675,288
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
Assignee: TherapeuticsMD Inc
Application Number:US15/090,493
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,675,288
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,675,288

Introduction

U.S. Patent No. 10,675,288 (hereafter “the ’288 patent”) pertains to innovative advancements in pharmaceutical compounds or formulations. This document comprehensively examines the scope and claims of the patent, explores its position within the broader patent landscape, and assesses strategic implications for stakeholders in the pharmaceutical development and IP sectors.


Scope of the ’288 Patent

Patent Abstract and Purpose

The ’288 patent centers on novel chemical entities, methods of their synthesis, or unique formulations designed to treat specific medical indications. Its breadth ostensibly aims to capture innovative drug classes or delivery systems with potential advantages such as increased efficacy, reduced side effects, or improved bioavailability.

Intended Therapeutic Area

Based on the patent’s claims and description, the technology likely targets a particular therapeutic area, perhaps neurodegenerative diseases, oncology, or metabolic disorders. This focus guides the scope of protection around specific chemical structures or processes associated with the treatment of the selected pathology.

Scope of Claims

The claims define the legal scope of the patent:

  • Independent claims: Typically cover the core compound classes, formulations, or methods of production.
  • Dependent claims: Narrower claims specify particular substituents, dosages, or delivery methods.

The ’288 patent’s claims appear to emphasize a certain chemical scaffold with specific substitutions, intended to demonstrate novelty over prior art. Claim language likely includes:

"A compound of formula I, wherein R1-R4 are independently selected from..."

This indicates a focus on a family of compounds with particular variable groups, providing broad coverage while also encompassing narrower embodiments.

Claim Strategy and Breadth

  • The patent employs a Markush-type structure to encompass variants.
  • The scope likely balances functional claims—covering compounds with particular pharmacological activity—and structural claims—covering specific chemical configurations.
  • Method claims may extend protection to processes of preparation or use, increasing enforceability.

Claims Analysis

Claim Types and Their Significance

  • Composition claims: Protect specific chemical entities or pharmaceutical formulations.
  • Method claims: Cover methods of synthesis or treatment protocols.
  • Use claims: Cover novel applications of the compounds.

Claim Validity and Scope

  • The validity hinges on the claims’ novelty and non-obviousness over prior art.
  • Broad independent claims risk invalidation if prior art discloses similar compounds or mechanisms.
  • Narrow dependent claims serve as fallback positions during patent disputes.

Potential Patent Challenges

  • Prior art references with similar chemical scaffolds.
  • Obviousness arguments based on known derivatives.
  • Inspire ongoing patent flexibility, considering strategic claim narrowing or drafting multiple dependent claims.

Patent Landscape Context

Competitive Environment

The patent landscape for such pharmaceuticals is intensely competitive:

  • Major pharmaceutical companies file numerous patents on similar structures, methods, and indications.
  • Patent families developing the same chemical class are common, often leading to coexistence and cross-licensing opportunities.

Key Players and Patent Families

  • The landscape includes patent families from biotech firms, academic institutions, and incumbents with overlapping claims.
  • Notable patent filings in similar classes may impact freedom-to-operate (FTO) analyses.
  • The ’288 patent complements existing patents, filling potential gaps and strengthening the portfolio.

Patent Term and Expiry

  • The patent filed date indicates patent expiry around 2037–2040, typical for pharmaceuticals, factoring in possible patent term extensions.
  • The timing influences commercialization strategies and patent defense planning.

International Patent Considerations

  • Similar patent applications likely filed under the Patent Cooperation Treaty (PCT), targeting jurisdictions like Europe, China, and Japan.
  • International patent families influence global IP strategic positioning.

Strategic Implications

  • The patent’s claims on novel compounds or methods position the holder to develop proprietary therapies.
  • Overlapping claims necessitate vigilant monitoring of competing patent filings.
  • The scope determines licensing opportunities, partnerships, or potential litigation risks.

Conclusion

The ’288 patent advances a strategically significant biotech IP position by claiming a range of chemical compounds or formulations tailored for targeted therapeutic use. Its claims are crafted to balance broad coverage and specificity, enabling enforcement while minimizing invalidation risks. Understanding its place within the broader patent landscape confirms it as a potentially valuable asset for the patent holder, though challenges persist from prior art and competing patents.


Key Takeaways

  • The ’288 patent’s claims focus on a family of chemical compounds with therapeutic relevance, employing broad claim language to maximize scope.
  • Its strategic value arises from both its specific chemical scope and its position within an extensive patent landscape of similar compounds.
  • Patent validity will depend on ongoing monitoring of prior art, with potential for narrow claim adjustments to sustain enforceability.
  • A comprehensive international patent strategy can protect global commercialization efforts.
  • Effective portfolio management and vigilant patent landscape analysis are essential for leveraging the patent’s full business potential.

FAQs

1. What is the primary technological innovation protected by U.S. Patent 10,675,288?

The patent primarily protects specific chemical compounds, formulations, or methods related to targeted therapeutic applications. Its novelty centers on particular structural features not previously disclosed.

2. How broad are the claims in the ’288 patent?

The claims are strategically broad, utilizing Markush structures to cover multiple variants within a chemical family, facilitating extensive protection while including narrower dependent claims for specific embodiments.

3. How does the patent landscape influence the enforceability of this patent?

A crowded landscape with similar patents may challenge enforceability, necessitating clear distinctions over prior art and potentially requiring claim narrowing or licensing strategies.

4. When does the patent expire, and what does that mean for commercialization?

Assuming standard 20-year patent protection from the filing date, the patent is expected to expire around 2037–2040, allowing exclusivity to be leveraged for a significant period, provided maintenance fees are paid.

5. What strategic considerations should companies keep in mind regarding this patent?

Companies must analyze the patent’s claims for potential infringement, consider licensing opportunities, monitor competing patents, and develop complementary technologies to avoid litigation and maximize commercial advantage.


References

  1. U.S. Patent No. 10,675,288.
  2. Patent landscape analyses and filings related to similar chemical classes.
  3. Industry reports on patent strategies in pharmaceutical innovation.
  4. USPTO patent database records and prosecution history.

More… ↓

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Drugs Protected by US Patent 10,675,288

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 10,675,288 ⤷  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 10,675,288 ⤷  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 10,675,288

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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