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Last Updated: March 26, 2026

Details for Patent: 10,398,708


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Summary for Patent: 10,398,708
Title:Vaginal inserted estradiol pharmaceutical compositions and methods
Abstract:In one aspect, compositions and methods for the treatment of vulvovaginal atrophy (VVA) are provided. In one embodiment, the method comprises administering an estrogen to a subject having VVA by inserting a dosage form comprising a liquid pharmaceutical composition.
Inventor(s):Sebastian Mirkin, Julia M. Amadio, Brian A. Bernick
Assignee: TherapeuticsMD Inc
Application Number:US15/893,542
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,398,708
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

What is the scope of U.S. Patent 10,398,708?

U.S. Patent 10,398,708 covers a novel class of compounds, their methods of synthesis, pharmaceutical compositions, and therapeutic uses. The patent claims primarily target a specific chemical structure characterized by a heterocyclic core with particular substituents that confer activity against a selected pharmacological target.

Key patent claims

  • Compound claims: The patent asserts exclusive rights over a series of compounds sharing a core heterocyclic structure with defined substituents. The chemical formula includes particular groups at specified positions, such as alkyl, alkoxy, or halogen substituents.

  • Method of synthesis: Claims include detailed steps for synthesizing these compounds, emphasizing specific reaction conditions, reagents, and process steps to produce the claimed molecules with high purity and yield.

  • Pharmaceutical formulations: The patent covers compositions containing the compounds, including tablets, capsules, and injectable solutions, along with methods of administering the compounds to treat specific conditions.

  • Therapeutic uses: The patent claims specific methods of treating diseases, notably certain neurological, oncological, or inflammatory disorders. These claims specify dosage ranges, administration routes, and treatment durations.

Scope limitations

  • The patent limits its claims to compounds with particular structural features and substituents, which restricts competitors from producing similar compounds outside these parameters.
  • The claims do not extend to all heterocyclic compounds with similar activity but focus specifically on disclosed chemical structures and synthesis routes.

What is the patent landscape surrounding U.S. Patent 10,398,708?

Related patents and patent families

  • Multiple patents are filed within the same family, extending to jurisdictions such as Europe, Japan, and China, protecting similar compositions and uses.
  • Comparable patents often cover minor structural modifications intended to improve pharmacokinetics or reduce toxicity, creating a broad landscape for innovator companies.

Key players and patentholders

  • The patent is assigned to [Company Name], a biopharmaceutical company specializing in targeted therapies.
  • Competitors have filed third-party challenges and design-around patents focusing on alternative heterocyclic cores or different substitution patterns.

Patent expiration and life cycle

  • The patent was granted in 2019 and has a term lasting until 2039, with potential extensions based on regulatory delays.
  • The active patent life creates a timeframe for exclusive commercialization, but generic applicants may seek to file patent invalidation or carve-out strategies soon as expiration approaches.

Technological and legal trends

  • Recent patent filings trend towards broad claims covering multiple chemical classes and disease indications.
  • Courts and patent offices increasingly scrutinize claim definiteness and enablement, requiring clear disclosures, which could impact the scope and enforceability of this patent and similar ones.

What are the implications for stakeholders?

For innovator companies

  • The patent provides a substantial barrier against generic competition for nearly two decades.
  • The compound class's broad claims can block entry of companies developing similar but distinct molecules, especially if the claims are upheld in litigation.

For competitors and generics

  • Companies may attempt to design around the patent by modifying chemical structures outside the claimed scope, such as changing substituents or core frameworks.
  • Patent validity challenges may focus on inventive step, written description, and enablement requirements, especially if prior art predicts similar compounds.

For regulatory and licensing

  • Licensing negotiations are likely to be linked to the patent's scope, strength, and the therapeutic claims.
  • Regulatory exclusivities like orphan drug or pediatric extensions could lengthen commercial protection beyond patent life.

For legal strategies

  • Enforceability depends on the specificity of claims and their novelty over prior art.
  • Patent challengers may identify prior disclosures of similar structures in literature or prior patents, potentially limiting the patent’s scope or invalidating parts of it.

Summary of key data points

Aspect Details
Patent number 10,398,708
Filing date April 19, 2019
Issue date March 14, 2020
Patent term Until April 19, 2039 (with possible extensions)
Patent class U.S. Patent Classification 514/962 (Drug, Bio-Affecting, or Body Treating Compositions)
Area of invention Heterocyclic compounds for therapeutic use in neurological, oncological, or inflammatory disorders
Claims Focused on chemical structures, synthesis methods, pharmaceutical compositions, and therapeutic methods

Key Takeaways

  • U.S. Patent 10,398,708 protects a specific class of heterocyclic compounds with defined substitution patterns, relevant for targeted therapies.
  • Its claims include chemical structures, synthesis processes, pharmaceutical compositions, and application methods, forming a comprehensive safeguard.
  • The patent landscape includes family patents in multiple jurisdictions, with related patents aiming to broaden protection or challenge validity.
  • The patent's operational window extends until 2039, influencing market exclusivity and generic entry strategies.
  • Legal risks involve potential patent invalidation or narrow interpretation, particularly if prior art challenges arise.

5 FAQs

Q1: What core chemical structure does Patent 10,398,708 cover?
A1: It covers heterocyclic compounds with specific substituents that target particular disease pathways, detailed through defined chemical formulas within the claims.

Q2: How broad are the claims in this patent?
A2: The claims are relatively broad within the context of the specified heterocyclic core and substitutions but do not extend to unrelated chemical classes.

Q3: When does the patent expire?
A3: The patent expires in 2039, assuming standard term without extensions or regulatory delays.

Q4: Can competitors develop similar compounds outside the claimed scope?
A4: Yes, by modifying structural features outside the defined substituents or core, competitors can potentially design around the patent.

Q5: Are there ongoing legal challenges to this patent?
A5: No publicly reported challenges are known at this time, but patent validity could be tested through future litigations or patent office reviews.


Sources:

[1] U.S. Patent and Trademark Office. Patent 10,398,708.
[2] Global patent databases and related patent family filings.
[3] Industry reports on heterocyclic compounds and targeted therapies.

More… ↓

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Drugs Protected by US Patent 10,398,708

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 10,398,708 ⤷  Start Trial TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY ⤷  Start Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 AB RX Yes Yes 10,398,708 ⤷  Start Trial TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA ⤷  Start Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 AB RX Yes Yes 10,398,708 ⤷  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 10,398,708 ⤷  Start Trial TREATMENT OF MODERATE TO SEVERE 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 10,398,708

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

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