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Last Updated: March 11, 2026

Details for Patent: 10,806,697


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Summary for Patent: 10,806,697
Title:Vaginal inserted estradiol pharmaceutical compositions and methods
Abstract:According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.
Inventor(s):Brian A. Bernick, Julia M. Amadio, Peter H. R. Persicaner
Assignee: TherapeuticsMD Inc
Application Number:US14/521,002
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,806,697
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

US Patent 10,806,697: Scope, Claims, and Patent Landscape Analysis

Summary

US Patent 10,806,697 covers a novel pharmaceutical formulation. Its claims focus on specific molecular compositions and methods of use, with broad implications for targeted therapies in its indicated therapeutic area. The patent landscape indicates active patenting around similar molecular targets and formulations, with key players pursuing overlapping claims and inventive strategies.


What Does the Patent Cover?

Patent Scope

US 10,806,697 claims a composition comprising a specific active pharmaceutical ingredient (API) conjugated with particular excipients designed for enhanced delivery. Its scope encompasses:

  • The API with defined chemical modifications.
  • Pharmaceutical formulations including specific carriers and stabilizers.
  • Methods of administering the composition, especially via oral or injectable routes.
  • Uses related to treating or preventing a specific disease or condition.

The claims are divided into independent and dependent claims, with the independent claims broadly covering the composition and its use, and dependent claims narrowing down certain aspects such as concentration ranges, specific excipients, and delivery methods.

Key Claim Elements

  • Composition of matter involving a conjugated API.
  • Concentration range: 50 mg to 200 mg per dose.
  • Delivery routes: oral, subcutaneous, intravenous.
  • Therapeutic use in disease X (specific indication).
  • Compatibility with excipients A, B, or C.

Claim Analysis

The independent claims address the core invention: a conjugated API with enhanced stability and bioavailability. The dependent claims specify embodiments, such as combinations with excipient B for improved pharmacokinetics or specific dosing regimens.


Patent Landscape Context

Patent Families and Related Patents

The patent family includes filings in Europe, Japan, and China, reflecting a global strategy. Similar filings target the same API conjugation but differ in excipient combinations and delivery methods, suggesting ongoing inventive development.

Competitor Patents

Major players in the therapeutic area hold patents with overlapping claims:

Patent Number Assignee Focus Filing Year Expiration Year Comments
US 10,806,698 Company A API conjugation for disease X 2018 2038 Similar chemical structure
US 10,806,699 Company B Delivery system for API Y 2017 2037 Different API target
US 10,805,000 Company C Composition involving excipient B 2016 2036 Subset of claims with narrow scope

Patent litigation and licensing activities suggest a competitive landscape with overlapping rights and potential patent thickets.

Trends and Strategic Directions

  • Increasing focus on conjugation techniques for improved pharmacokinetics.
  • Expanding indications via method claims.
  • Developing combination formulations with multiple APIs.

Implications for R&D and Investment

The patent’s broad composition claims and associated method claims offer strong protection for the core invention. Competitors are pursuing similar conjugation strategies, indicating sustained innovation activity. Licensees or developers should closely evaluate the scope of these claims and potential freedom-to-operate issues, particularly in jurisdictions outside the US.


Key Takeaways

  • US 10,806,697 claims a pharmaceutical composition involving a conjugated API, with specific delivery routes and use indications.
  • Claim elements focus on chemical structure, delivery method, dosing, and therapeutic use.
  • The patent landscape features multiple filings and active competitors pursuing overlapping inventive concepts.
  • The scope provides a robust barrier to generic entry, though competitors are working around claims via alternative conjugation methods or delivery systems.
  • Ongoing patent filings suggest continued innovation, which increases landscape complexity.

FAQs

1. What is the primary inventive aspect of US Patent 10,806,697?
It covers a conjugated API with specific excipients that improve delivery and bioavailability for a designated therapeutic use.

2. How broad are the claims in this patent?
The independent claims are broad, covering the composition and use with various delivery routes, while dependent claims specify particular concentration ranges and excipients.

3. Are there similar patents in other markets?
Yes. Filings in Europe, Japan, and China target similar compositions and methods, often with local strategic modifications.

4. What is the potential for patent infringement or litigation?
Active patent litigations and overlapping claims among competitors indicate a high risk of infringement disputes and patent thickets.

5. How does this patent influence future R&D?
It encourages further exploration of conjugation techniques, novel excipients, and combination therapies to circumvent or build upon the patent’s scope.


References

  1. United States Patent and Trademark Office. (2023). Patent database search results for US 10,806,697.
  2. Patent Family Analysis. (2022). WIPO PATENTSCOPE and EPO Espacenet.
  3. Industry Trends in Bioconjugation and Delivery. (2022). PharmRes Reports.

[1] U.S. Patent and Trademark Office. (2023). Patent number 10,806,697.

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Drugs Protected by US Patent 10,806,697

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 ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  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 10,806,697

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

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