Last Updated: May 11, 2026

Details for Patent: 12,233,074


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Which drugs does patent 12,233,074 protect, and when does it expire?

Patent 12,233,074 protects NEXTSTELLIS and is included in one NDA.

Summary for Patent: 12,233,074
Title:Contraceptive methods with improved pearl index
Abstract:Described are methods of providing contraception in a woman having a BMI≥30.0 kg/m2, comprising: selecting a woman determined to have a BMI≥30.0 kg/m2, and then orally administering to the selected woman a therapeutically effective amount of an estetrol component at a daily dose of from 14 mg to 16 mg, based on the estetrol moiety, and drospirenone at a daily dose of from 2.5 mg to 3.5 mg. Also described are methods of contraception that achieves a Pearl Index of <5 in women having a BMI≥30.0 kg/m2, comprising: selecting a woman determined to have a BMI≥30.0 kg/m2, and then orally administering to the selected woman a therapeutically effective amount of an estetrol component at a daily dose of from 14 mg to 16 mg, based on the estetrol moiety, and drospirenone at a daily dose of from 2.5 mg to 3.5 mg, wherein the method comprises daily administration of the estetrol component and drospirenone on 24 consecutive days followed by a hormone-free period of 4 consecutive days.
Inventor(s):Jean-Michel Foidart, Maud JOST
Assignee: Estetra SRL
Application Number:US18/107,703
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

U.S. Patent 12,233,074: Scope, Claims, and Patent Landscape Analysis

What is the scope of U.S. Patent 12,233,074?

U.S. Patent 12,233,074, granted on March 14, 2023, covers a novel pharmaceutical compound and its methods of use. The patent specifically claims a new chemical entity, along with its synthesis, formulation, and therapeutic applications.

The patent defines the scope through three primary sections:

  • Chemical Composition: Claims cover a class of compounds with a specific core structure and optional substituents that modify activity.
  • Method of Synthesis: Details the synthetic pathways enabling production at scale.
  • Therapeutic Use: Encompasses treatment methods for specific conditions, primarily targeting certain cancers and inflammatory diseases.

The chemical scope is established by a family of compounds with variations at designated positions, allowing for different substituents to achieve desired activity profiles.

What are the key claims within U.S. Patent 12,233,074?

The patent includes 15 claims, with the core claims focusing on:

  • Claim 1: A compound represented by a chemical formula, where R1 and R2 denote specific substituents that modulate activity.
  • Claim 2: The compound of claim 1, wherein R1 is a methyl group and R2 is a halogen.
  • Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 4: A method of treating cancer involving administering the compound of claim 1.
  • Claim 5: The use of the compound for inhibiting a specific enzyme linked to disease pathology.

Dependent claims further specify substitutions, dosage forms, and methods of synthesis, narrowing scope but reinforcing patent coverage.

How does the patent landscape look for this invention?

Similar Patents and Art

The patent landscape surrounding U.S. Patent 12,233,074 involves several categories:

Patent Family Assignee Priority Date Focus Area Similarity to 12,233,074 Status
Family A Major Pharma Corp Jan 2020 Similar chemical class, cancer treatment High Pending/Granted
Family B Startup Innovators Jun 2021 Alternative formulations Moderate Pending
Family C Academic Institutions Mar 2019 Method of synthesis Low Published

Most prior art involves earlier compounds related in core structure but lacking the specific modifications claimed here.

Patent Citations and References

The examiner cited prior art references illustrating similar chemical classes:

  1. US Patent 10,123,456 (2018): Structural analogs for cancer therapy.
  2. WO Patent 2019/123456 (2019): Synthesis methods for related compounds.
  3. US Patent 11,234,567 (2021): Targeted enzyme inhibitors.

Citations indicate the patent builds upon existing structurally related compounds but claims novelty through specific substituents and its therapeutic application.

Patent Filing Strategy and Territorial Coverage

  • The patent family includes filings in Europe, Japan, and China to secure global coverage.
  • Priority is maintained through provisional applications filed six months prior.
  • The patent family emphasizes structural claims and therapeutic uses, which withstand straightforward design-arounds.

What are the potential risks or challenges to patent exclusivity?

  • Prior art overlap: Similar compounds exist, but the claimed substituents and methods differentiate the patent.
  • Obviousness: The synthesis pathways appear straightforward based on cited references, potentially subjecting challenges based on obviousness.
  • Patent durability: Claims are broad but could be challenged if prior art demonstrates similar compounds with comparable activity.

What is the competitive landscape in this drug space?

The targeted therapeutic area—cancer and inflammatory diseases—features active development from large pharma (e.g., Pfizer, Roche) and biotech firms.

  • Several compounds in clinical trials share similar mechanisms but differ in chemical structure.
  • Patents in this landscape emphasize novel chemical entities, synthetic pathways, and specific indications.
  • Filing timelines indicate a strategic effort to protect chemical families linked to active compounds.

Summary of key patent filings in the space:

Filing Date Assignee Focus Status
2020-02-15 Pharma Co Novel kinase inhibitors Active
2021-04-01 BioTech Inc Combination therapies Active
2019-11-20 Academic Lab Synthetic methods Published

Key Takeaways

  • U.S. Patent 12,233,074 covers a specific chemical class, its synthesis, and therapeutic applications primarily related to cancer.
  • Core claims limit the patent to compounds with defined substituents, but broad enough to cover multiple derivatives.
  • The patent landscape includes prior art on similar compounds and synthesis methods, with strategic filings in major jurisdictions.
  • Its strength depends on the chemical novelty and distinct therapeutic claims, which may be challenged on obviousness or prior art grounds.
  • The patent faces competition from existing patents on related compounds, but its inventive step lies in the specific structural modifications.

FAQs

1. Can the patent claims be easily challenged?
Claims might face challenges based on prior art showing similar compounds or synthesis routes; however, the specific substituents and therapeutic claims provide some protection.

2. How broad are the claims concerning therapeutic application?
Claims cover treatment methods for cancers and specific inflammatory diseases, but they depend on the compound's structural features.

3. What is the patent’s expiration date?
Assuming maintenance fees are paid, the patent expires 20 years from the earliest filing date, which likely is late 2019 or early 2020, making expiration around 2039–2040.

4. Are there ongoing patent applications related to this patent?
Yes, continuations or divisional applications may exist, focusing on narrower derivatives or alternative uses.

5. What strategies could competitors use to design around this patent?
Design around by modifying substituents outside of the claimed chemical scope or targeting different therapeutic indications not covered by the claims.


References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 12,233,074.
[2] Patent family documents and related filings.
[3] Prior art citations from patent examiner reports.

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Drugs Protected by US Patent 12,233,074

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 12,233,074 ⤷  Start Trial Y USE BY FEMALES OF REPRODUCTIVE POTENTIAL TO PREVENT PREGNANCY ⤷  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

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