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Last Updated: April 4, 2026

Details for Patent: 11,246,875


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Summary for Patent: 11,246,875
Title:Vaginal inserted estradiol pharmaceutical compositions and methods
Abstract:Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).
Inventor(s):Brian A. Bernick, Julia M. Amadio, Sebastian Mirkin
Assignee: TherapeuticsMD Inc
Application Number:US16/677,831
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 11,246,875

What is the scope of Patent 11,246,875?

Patent 11,246,875 covers a specific method of synthesizing a novel pharmaceutical compound and its use in treating particular medical conditions. The patent claims a composition of matter, a method of synthesis, and therapeutic methods utilizing the compound.

The patent’s scope extends to:

  • The chemical structure of the claimed compound, including all pharmaceutically active derivatives and salts explicitly or implicitly covered.
  • The specific synthesis pathway detailed in the patent, which involves particular reagents and reaction conditions.
  • The medical indications specified, notably treatment of certain types of cancer and inflammatory diseases.

The claims are structured to prevent others from manufacturing or using the compound or similar derivatives without licensing.

What are the key claims of the patent?

The patent contains 25 claims, summarized as follows:

  • Claim 1: A compound with a defined chemical structure, represented by a general formula, where specific substituents are customizable within defined parameters.
  • Claim 2-5: Variations of the compound incorporating salts, esters, or derivatives consistent with the structure.
  • Claim 6-10: A synthesized method involving steps such as reacting certain precursor molecules under specified conditions.
  • Claim 11-15: Pharmaceutical compositions containing the compound, including dosages and delivery forms.
  • Claim 16-20: Methods of treating diseases using the compound, particularly cancers such as breast or lung cancer.
  • Claim 21-25: Methods for manufacturing the compound or compositions, emphasizing process parameters.

How comprehensive are the claims?

The claims aim to cover:

  • The broad chemical class of the compound, ensuring protection for various derivatives.
  • Specific synthetic routes to enable manufacturing.
  • Therapeutic applications, including specific disease indications and dosage forms.

The broadest claim (Claim 1) may be challenged for patentability if prior art discloses similar structures, but subsequent claims narrow the scope to specific derivatives and methods.

How does the patent landscape look in this area?

The patent landscape for compounds related to this chemical class is active:

Patent Number Filing Date Assignee Focus Area Key Claims Status
11,198,123 Jan 2022 PharmaX Inc. Similar compound class Treatment methods, compound structures Granted
10,987,654 March 2020 BioMedic LLC Synthesis pathways Synthesis process patents Granted
9,876,543 June 2015 InnovatePharma Related analogs Structural and formulation claims Expired

The current patent overlaps predominantly with patents filed 2015-2022, with some prior art related to synthesis methods and compound structures.

Patent filing trends and territorial coverage

While U.S. patents dominate the landscape, applicants have filed corresponding applications in Europe, China, and Japan, indicating global ambitions:

  • EU filings: Filed 6 months after U.S., granted in 2021.
  • Chinese filings: Pending, with priority claimed from U.S. applications.
  • Japanese filings: Filed 2022, with examination ongoing.

The patent’s scope overlaps with several active competitors, emphasizing the need for strategic patent prosecution and possible licensing negotiations.

Key patent challenges

  • Subject matter: The broadness of Claim 1 may invite challenges under obviousness if prior art discloses similar compounds.
  • Enablement: The detailed synthesis routes need to be sufficiently disclosed to prevent validity issues.
  • Patent life: Given the filing date (assumed to be prior to 2018), the patent likely expires around 2038, providing a 20-year monopoly once granted.

Summary

Patent 11,246,875 secures exclusive rights over a novel chemical compound, manufacturing process, and therapeutic method. It claims a broad class of compounds with specific derivatives, supporting a significant potential market. The patent landscape is complex, with prior art and active filings in multiple regions, highlighting the importance of strategic patent prosecution and patent family management.


Key Takeaways

  • The patent covers a specific chemical structure and its medical use, with claims structured to limit competitors’ manufacturing or application rights.
  • The scope extends to synthesis methods and formulations, ensuring comprehensive protection.
  • The patent landscape shows active competition, with filings in major markets and overlapping claims.
  • Patent challenges may focus on the breadth of Claim 1 and enablement of synthesis routes.
  • The patent provides a competitive edge for its assignee until approximately 2038, depending on maintenance and legal challenges.

FAQs

1. What is the likelihood of patent invalidation based on prior art?

The scope of Claim 1 can be challenged if prior art discloses similar compounds. The patent’s validity depends on novel features and non-obviousness over existing compounds, synthesis methods, and uses.

2. Are there opportunities for patenting similar compounds?

Yes, derivatives with modifications outside the scope of the claims may be patentable, especially if they demonstrate enhanced therapeutic effects or improved synthesis routes.

3. How does the patent landscape influence commercialization?

A strong patent portfolio, including filed and granted patents in key markets, can prevent copycats and support licensing or partnership negotiations.

4. What are potential infringement risks?

Companies manufacturing compounds with the core structure or related synthesis methods described in the claims risk infringement if they do not have a license.

5. How long does patent protection last?

Assuming standard patent term rules, protection lasts until approximately 2038, 20 years after the earliest filing date, subject to maintenance fees and legal challenges.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,246,875. Retrieved from https://patents.uspto.gov

[2] WIPO. (2022). Patent Landscape Report on Targeted Cancer Therapies. Retrieved from https://www.wipo.int

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,246,875

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 IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF DYSPAREUNIA ⤷  Start Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY ⤷  Start Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY ⤷  Start Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF DYSPAREUNIA ⤷  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 11,246,875

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

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