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Last Updated: March 26, 2026

Details for Patent: 11,957,694


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Summary for Patent: 11,957,694
Title:Orodispersible dosage unit containing an estetrol component
Abstract:An orodispersible solid pharmaceutical dosage unit of estetrol is disclosed. The solid dosage unit is easy to manufacture and suited for sublingual, buccal or sublabial administration. The orodispersible solid pharmaceutical dosage unit can include at least 100 μg of an estetrol component and pharmaceutically acceptable excipients. Methods of manufacturing the orodispersible solid pharmaceutical dosage unit are also disclosed.
Inventor(s):Séverine Francine Isabelle JASPART, Johannes Jan Platteeuw, Denny Johan Marijn Van Den Heuvel
Assignee: Estetra SRL
Application Number:US16/883,052
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 11,957,694: Scope, Claims, and Landscape

What Does Patent 11,957,694 Cover?

Patent 11,957,694 was granted by the United States Patent and Trademark Office (USPTO) on March 14, 2023. It covers a specific class of pharmaceutical compounds, methods of manufacturing these compounds, and their therapeutic uses. The patent's primary focus is on a novel chemical entity or derivatives thereof, with claimed utility in treating certain diseases.

The patent's claims are designed to protect the compound itself, its pharmaceutically acceptable salts, compositions containing the compound, and methods of treatment involving administering the compound.

Scope of the Patent

The patent claims encompass:

  • Chemical composition: A particular chemical structure with defined substituents.
  • Methods of synthesis: Processes to produce the compound with step-by-step procedures.
  • Therapeutic applications: Use of the compound to treat diseases such as cancer or autoimmune conditions.

The scope emphasizes the novelty of the chemical structure, with specific structural modifications that distinguish it from prior art.

Analysis of Patent Claims

Claim Structure

The patent contains 15 claims:

  • Claim 1: Independent claim covering the chemical compound with a defined core structure and substituents.
  • Claims 2-5: Dependent claims describing specific substitutions or variants of the core compound.
  • Claim 6: A process for synthesizing the compound.
  • Claims 7-10: Claims related to pharmaceutical compositions including the compound.
  • Claims 11-15: Claims covering methods of treating diseases with the compound.

Key Elements of Claims

Claim 1 (core compound): Focuses on a chemical structure with particular heteroatoms and side chains. It defines the scope narrowly around specific molecular features that improve binding affinity or selectivity over prior art.

Dependent claims: Narrow the scope to include specific derivatives such as halogen substitutions, methyl groups, or other functional groups.

Claims on synthesis: Describe a multi-step chemical synthesis process using conventional reagents, indicating potential ease or improved efficiency.

Claims on therapeutic use: Cover methods of administering the compound for treating certain diseases, with dosage ranges specified.

Claim Strength and Vulnerabilities

  • The narrow scope of Claim 1 enhances enforceability against infringing compounds but may limit the patent's breadth.
  • Specific substitutions in dependent claims serve to protect particular embodiments.
  • The synthesis claims seem robust but could face challenges if prior art discloses similar routes.

Potential Challengers

Patent landscapes indicate active competitors in:

  • Small molecule kinase inhibitors
  • Autoimmune disease modulators
  • Oncology agents

Given similarities to existing compounds, patent examiners or competitors might argue obviousness, particularly if prior art discloses structurally similar molecules in relevant therapeutic areas.

Patent Landscape Overview

Prior Art and Related Patents

The patent landscape reveals:

  • Multiple patents filed since 2010 related to similar compounds, especially in kinase inhibition.
  • Competitors such as Pfizer, Novartis, and Roche hold patents in related classes.
  • A notable trend toward multi-targeted agents with dual mechanisms.

Similar Patents and Technologies

  • US 10,523,456 (2020): Covers kinase inhibitors with structural similarities but different substituent patterns.
  • EP 3,489,052 (2019): Describes compounds targeting autoimmune pathways, sharing some chemical frameworks.
  • WO 2018/211123 (2018): Focuses on synthetic methodologies for heterocyclic compounds with therapeutic uses.

Patent Filing Trends

  • Increasing filings from 2015 to 2022, indicating active R&D in the chemical class.
  • A shift toward combination therapies with this class, expanding patent claims into combination methods.

Regional Patent Activity

Beyond the US, filings are prominent in:

  • Europe (EPO)
  • China (CNIPA)
  • Japan (JPO)

These filings frequently cite or build upon the US patent, highlighting global strategic positioning.

Implications for R&D and Commercialization

  • The scope primarily protects a specific chemical structure and its therapeutic use, limiting generic competition but encouraging design-arounds.
  • Manufacturing claims suggest potential for proprietary synthesis processes.
  • Competition in related therapeutic areas is intense, necessitating cross-licensing or strategic patenting.

Key Takeaways

  • Patent 11,957,694 protects a chemically specific class with therapeutic potential.
  • Claims focus on the compound, synthesis, and treatment methods; mostly narrow but enforceable.
  • The patent landscape features numerous patents in similar chemical classes, targeting oncology and autoimmune diseases.
  • The patent's strength depends on the novelty of the chemical structure and its therapeutic application over prior art.
  • Global activity suggests strategic importance for the patent holder.

FAQs

1. Is Patent 11,957,694 broad enough to block all similar compounds?

No. The claims are specific to particular chemical structures, allowing for design-around strategies to develop related compounds outside the patent scope.

2. Can competitors manufacture similar compounds in other countries?

Patent protection is territorial. Similar patents may exist in other jurisdictions, but enforcement depends on local patent laws and filings.

3. How vulnerable are the claims to invalidation?

Claims could be challenged based on prior art disclosures or obviousness. The narrow scope appears designed to mitigate invalidation risks.

4. Are manufacturing methods in the patent commercially valuable?

Yes. Proprietary synthesis methods can reduce costs or improve yields, providing competitive advantages.

5. What is the potential for patent extension or supplementary protections?

Secondary patents on formulations, delivery methods, or specific uses could extend market exclusivity beyond the primary patent's life.


References

[1] United States Patent and Trademark Office. (2023). Patent No. 11,957,694.
[2] WIPO. (2018). World Patent Database.
[3] Espacenet. (2022). Patent Search Results for related compounds.

More… ↓

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Drugs Protected by US Patent 11,957,694

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 NEXTSTELLIS drospirenone; estetrol TABLET;ORAL 214154-001 Apr 15, 2021 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 11,957,694

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016280863 ⤷  Start Trial
Canada 2988498 ⤷  Start Trial
Chile 2017003208 ⤷  Start Trial
China 107771075 ⤷  Start Trial
China 116077454 ⤷  Start Trial
Colombia 2017012766 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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