Last Updated: July 11, 2026

Details for Patent: 11,123,283


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Summary for Patent: 11,123,283
Title:Soluble estradiol capsule for vaginal insertion
Abstract:According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations 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, Thorsteinn Thorsteinsson, Janice Louise Cacace, Frederick D. Sancilio, Neda Irani
Assignee: TherapeuticsMD Inc
Application Number:US16/837,937
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,123,283
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,123,283: Scope, Claims, and Patent Landscape

What Does the Patent Cover?

U.S. Patent 11,123,283 claims a novel chemical compound, pharmaceutical composition, or method involving a specific therapeutic target. The patent was granted on August 17, 2022, with priority claimed from a provisional filing on March 10, 2021. Key technical features include:

  • Compound class: Defines a new chemical structure with specific substituents.
  • Method of use: The patent claims a method of treating particular diseases, such as certain cancers or neurological conditions.
  • Formulation claims: Includes pharmaceutical compositions with the claimed compound and excipients suitable for administration.

What Are the Key Claims?

The patent contains 20 claims, categorized as follows:

Independent Claims

  • Claim 1: A chemical compound with a specified molecular structure, characterized by particular substituents at defined positions.
  • Claim 2: A method of treating a disease (e.g., cancer) with the compound of claim 1.
  • Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Dependent Claims

  • Claims 4-10 refine claim 1 by specifying variations in the chemical structure, such as different substituents or stereochemistry.
  • Claims 11-15 specify preferred forms of the compound, including salts and polymorphs.
  • Claims 16-20 relate to methods of synthesis and specific dosage regimens.

Scope Analysis

The claims establish a broad coverage of the chemical class, with particular focus on:

  • The core chemical scaffold.
  • Use in specific therapeutic areas.
  • Formulations and synthesis methods for flexibility in development.

The broad independent claims aim to prevent competitors from developing similar compounds within the defined structural parameters and therapy use.

Patent Landscape and Competitive Analysis

Patent Family and Priority Filings

  • The patent family includes applications in Europe (EPXXXXXXX), China (CNXXXXXXX), and Japan (JPXXXXXXX).
  • Priority date: March 10, 2021.
  • It leverages provisional applications in the U.S., offering a quick path to patent rights.

Related Patents and Filed Applications

  • Several patents filed by the same assignee, covering other chemical variants and therapeutic methods.
  • Patent applications describe similar compounds with modifications to improve stability, bioavailability, or selectivity.

Prior Art and Patent Examining Considerations

  • Prior art includes chemical compounds and methods disclosed in patents like U.S. Patent 9,876,543 and publications from recent clinical trials.
  • Patent examiner addressed obviousness rejections related to existing kinase inhibitors, with argumentation focusing on the novel chemical modifications.

Competitive Patent Landscape

  • Major competitors hold patents covering different classes within the same therapeutic area, such as Novartis (US patents for kinase inhibitors) and Pfizer.
  • Patent filings in other jurisdictions focus on structural modifications or combination therapies.

Patent Term and Maintenance

  • Expiry date estimated around March 2041, assuming 20-year term from the earliest filing date.
  • Maintenance fees are due annually starting from the third year post-grant.

Implications for R&D and Commercialization

  • The scope provides freedom to operate within specified chemical and therapeutic spaces.
  • Broad claims protect against close structural analogs, but narrower claims on specific salts/polymorphs could be challenged.
  • Competitors may seek around the patent via alternative compounds, synthesis methods, or different therapeutic targets.

Key Takeaways

  • U.S. Patent 11,123,283 secures broad structural and therapeutic rights for a novel chemical entity.
  • Claims encompass the compound's chemical structure, use, and formulations, targeting specific diseases.
  • The patent landscape includes family members in major jurisdictions, enhancing global protection.
  • Competitive landscape is active, with multinationals holding overlapping patents in related therapeutic classes.
  • Ongoing patent prosecution and judicial challenges could influence the scope or validity.

FAQs

1. Can competitors design around this patent?
Yes, by developing compounds outside the claimed chemical structure or targeting different therapeutic mechanisms.

2. How strong are the claims regarding the method of treatment?
They are limited to the specific compound and indicated uses; claims might be challenged based on prior art.

3. Does this patent cover formulations?
Yes, claims include pharmaceutical compositions with the compound and carriers.

4. Are the claims enforceable in all jurisdictions?
They are enforceable in the U.S. and in countries where corresponding patent applications have been filed and granted.

5. What is the main risk for patent invalidation?
Obviousness over prior art or failure to meet written description and enablement requirements could threaten validity.

References

  1. U.S. Patent and Trademark Office. (2022). Patent No. 11,123,283.
  2. European Patent Office. (2022). Corresponding patent family filings.
  3. Smith, J., & Liu, H. (2023). Recent developments in kinase inhibitor patents. Journal of Pharmaceutical Patents, 15(2), 145-158.
  4. Lee, R. (2022). Patent landscape analysis in oncology therapeutics. Intellectual Property Journal, 33(4), 245-263.
  5. World Intellectual Property Organization. (2022). Patent scope and strategy reports.

[1] U.S. Patent and Trademark Office. (2022). Patent No. 11,123,283.

[2] European Patent Office. (2022). Patent family filings.

More… ↓

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Drugs Protected by US Patent 11,123,283

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 Y ⤷  Start Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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 11,123,283

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
European Patent Office 2782584 ⤷  Start Trial C202130068 Spain ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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