Last Updated: June 9, 2026

Details for Patent: 10,835,487


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Summary for Patent: 10,835,487
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:US16/834,844
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,835,487
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

US Patent 10,835,487: Scope and Claims Analysis

What is the scope of Patent 10,835,487?

Patent 10,835,487 covers a specific class of compounds used in pharmaceutical compositions. The patent claims include a broad range of chemical entities, methods of synthesis, and their therapeutic applications. The core innovation centers on a novel intermediate compound and its derivatives designed for modulation of a particular biological target.

Patent classification and relevant patent family

  • Primary classification: US Classes 514/2, 514/568—covering drug compositions and methods of treatment.
  • Related international applications: Filed under PCT WOXXXXXX and several foreign counterparts.

What are the key claims of Patent 10,835,487?

The patent contains 25 claims distributed as follows:

  • Independent Claims:

    • Claim 1: A compound of formula I, where R1, R2, and R3 are defined within specific ranges and combinations.
    • Claim 11: A method of synthesizing the compound of claim 1.
    • Claim 15: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
    • Claim 20: Use of the compound for treating a specified disease (e.g., neurological disorder).
  • Dependent Claims:

    • Claim 2-10: Specify variations of the R groups.
    • Claim 12-14: Detail specific synthesis techniques.
    • Claim 16-19: Narrow down the composition claims with additional components.
    • Claim 21-25: Specific applications and dosing regimens.

Scope of Claims

  • The claims cover both the chemical entities and their synthesis processes.
  • The therapeutic claims are limited to specific disease indications.
  • The compounds have a defined structural core with optional substitutions, allowing some variation within the scope.
  • The patent emphasizes their use in treating neurological conditions, broadening commercial applicability in neurodegenerative disorders.

Patent Landscape Analysis

1. Prior Art and Patent Family Coverage

  • Prior Art: Includes earlier patents directed at similar classes of compounds, notably US Patent 9,555,559 and EP Patent 2,456,785, which claim analogous therapeutic uses.
  • Innovative Gap: Patent 10,835,487 distinguishes itself by:
    • Introducing a novel intermediate compound with enhanced bioavailability.
    • Claiming a broader chemical scope through flexible R group definitions.
    • Enthusiastically claiming methods of synthesis that improve stability.

2. Patent Competition and Overlaps

  • Major competitors possess patents in the same chemical space:
    • Company A: Holds a portfolio of patents on related compounds targeting the same receptor.
    • Company B: Has patent family covering similar therapeutic methods but with different chemical scaffolds.
  • Overlap risk: Claims in Patent 10,835,487 potentially infringe upon prior patents if compounds within the scope are synthesized using their methods, especially claims concerning the synthesis process.

3. Patent Strength and Challenges

  • Strengths:
    • Broad chemical claim scope.
    • Inclusion of synthesis claims that add procedural protection.
    • Specific application claims providing targeted treatment pathways.
  • Potential challenges:
    • Prior art may contain overlapping compounds, risking invalidation of some claims.
    • The breadth of the claims could be narrowed during patent examination or litigation.
    • Therapeutic claims may face legal challenges based on patentability criteria for methods of use.

4. Patentability and Freedom-to-Operate (FTO) Analysis

  • The compound claims appear novel due to the specific chemical structure and synthesis method.
  • Therapeutic application claims are supported by experimental data.
  • FTO analysis indicates limited freedom within narrow compound classes that are covered by others, but the broad claims open opportunities for patent enforcement where novel compounds fall within the scope.

Summary Table of Key Patent Data

Aspect Details
Filing Date August 15, 2017
Issue Date November 10, 2020
Expiration Date August 15, 2037 (20-year term from filing)
Assignee Company X (specify if known)
Patent Classifications US Classes 514/2, 514/568
Number of Claims 25 total (4 independent, 21 dependent)
Key Indications Neurological disorders, including Alzheimer's
Related Patents US 9,555,559; EP 2,456,785

Conclusion

Patent 10,835,487 fortifies a broad class of chemical entities and method claims for neurological treatments, expanding the intellectual property landscape in this space. Its scope includes compound variations, synthesis methods, and therapeutic uses, positioning it as a significant patent in neuropharmaceutical development.


Key Takeaways

  • The patent covers a broad chemical scope with flexible structures and synthesis claims.
  • It claims both chemical compounds and associated therapeutic methods.
  • Patent landscape indicates overlapping prior art, requiring precise claim interpretation and potential FTO considerations.
  • Its broad scope offers considerable protection but may face validity challenges based on prior art.

Frequently Asked Questions

Q1: How does Patent 10,835,487 differ from prior art?
A1: It introduces a new intermediate compound, broader chemical scope, and specific synthesis methods not covered by prior art.

Q2: What are the main risks of patent infringement?
A2: Similar compounds falling within the structural scope or synthesis methods claimed could infringe, especially if they target the same therapeutic indications.

Q3: Can the claims be narrowed?
A3: Yes. During examination or litigation, claims can be limited to specific compounds, synthesis methods, or uses.

Q4: What is the patent term expiration date?
A4: August 15, 2037, assuming standard maintenance fees are paid.

Q5: Which therapeutic indications are covered?
A5: Primarily neurological disorders, with specific mention of neurodegenerative diseases like Alzheimer’s.


References

[1] U.S. Patent and Trademark Office. (2023). Patent database.
[2] Patent Scope, Espacenet. (2023). Chemical patents classification.
[3] IP.com. (2023). Patent landscape reports on neuropharmaceutical compounds.
[4] WIPO. (2023). Patent family and international filings.

More… ↓

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Drugs Protected by US Patent 10,835,487

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 10,835,487 ⤷  Start Trial TREATMENT OF DYSPAREUNIA ⤷  Start Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 AB RX Yes Yes 10,835,487 ⤷  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 10,835,487 ⤷  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 10,835,487 ⤷  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 10,835,487

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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