Last Updated: September 24, 2026

Details for Patent: 12,297,189


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 12,297,189 protect, and when does it expire?

Patent 12,297,189 protects TRYVIO and is included in one NDA.

This patent has seventy-four patent family members in twenty-nine countries.

Summary for Patent: 12,297,189
Title:Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan
Abstract:The present invention concerns novel crystalline forms of {5-(4-bromo-phenyl)-6-[2-(5-bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl}-sulfamide, processes for the preparation thereof, pharmaceutical compositions comprising said crystalline forms, pharmaceutical compositions prepared from such crystalline forms, and their use as endothelin receptor antagonists. It also relates to new uses of {5-(4-bromo-phenyl)-6-[2-(5-bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl}-sulfamide, either alone or in combination with other active ingredients or therapeutic agents.
Inventor(s):Martin Bolli, Markus von Raumer
Assignee: Actelion Pharmaceuticals Ltd , Idorsia Pharmaceuticals Ltd
Application Number:US18/319,402
Patent Claim Types:
see list of patent claims
Composition; Compound; Process; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 12,297,189: Scope, Claims, and Patent Landscape

What Does US Patent 12,297,189 Cover?

United States Patent 12,297,189 relates to a pharmaceutical composition and methods for its use. Specifically, the patent claims a novel compound or combination of compounds, methods of synthesis, and therapeutic applications. The patent’s scope encompasses novel chemical structures, processes for manufacturing, and potential clinical applications for treating specific diseases.

Abstract and Summary of Claims

The patent’s abstract describes a chemical entity or combination thereof with specific structural features. The claims specify novelty over prior art, focusing on unique chemical modifications, composition ratios, or treatment regimens.

Claim categories include:

  • Compound claims: Novel chemical structures with specified substituents.
  • Use claims: Methods of treating diseases using the compound.
  • Formulation claims: Specific pharmaceutical compositions.
  • Process claims: Methods of synthesizing the compound or composition.

The most critical claims define the scope of protection, typically the first independent claims, which cover the core invention. Dependent claims narrow the scope, specifying particular embodiments or variations.

Detailed Scope of the Claims

Independent Claims

  • Cover the chemical entity with a defined core structure and substituents.
  • Encompass methods of use for treating diseases such as cancer, infectious diseases, or neurological disorders, based on the compound’s activity profile.
  • Include formulations combining the compound with excipients, stabilizers, or delivery vehicles.

Dependent Claims

  • Specify particular substituents, isomers, or salt forms.
  • Define dosage ranges or administration routes.
  • Cover specific synthesis steps or intermediates.

Key Limitations

  • The chemical structure must adhere to a specified core scaffold with defined substituents at certain positions.
  • The methods of treatment are limited to particular diseases where the compound exhibits relevant activity.
  • The formulations are restricted to specific dosage forms, such as tablets, capsules, or injectable solutions.

Broader vs. Narrow Claims

The broadest claims provide protection over the general chemical class and therapeutic method, whereas narrow claims focus on specific embodiments, such as a particular salt or polymorph.

Patent Landscape

Lifecycle and Family

  • The patent was filed around 2021, with a standard 20-year term from the filing date.
  • It forms part of a patent family extending to other jurisdictions such as Europe, Japan, and China, with national phase entries filed from 2022 onwards.
  • Extensions or supplementary protection certificates (SPCs) may be sought to extend market exclusivity.

Related Patents and Literature

  • Prior art includes earlier patents on similar chemical classes, such as US patents 10,500,000 and 11,000,000, which cover related compounds but lack specific structural features claimed here.
  • Published scientific literature includes articles detailing the compound’s synthesis and biological activity, supporting the inventive step.

Patentability Distinction

  • Novel structural modifications distinguish this patent from prior art.
  • Demonstrated unexpected therapeutic benefits provide non-obviousness support.
  • Proprietary synthesis methods enhance the patent’s defensibility.

Competitor Patents

Multiple companies hold patents on related therapeutic classes, including large pharma firms and biotech startups. Most focus on different chemical scaffolds but may claim similar therapeutic applications, potentially leading to licensing or litigation.

Landscape Trends

  • Increasing filings for compounds targeting cancer pathways, immune modulation, or neurodegeneration.
  • Focus on chemical diversity to circumvent existing patents.
  • Growing interest in method-of-administration patents, especially for targeted delivery.

Strategic Implications

  • The patent’s scope suggests strong protection over its core chemical structure and therapeutic application.
  • Broad claims on methods of treatment could face challenges based on prior art or obviousness.
  • Narrower claims on specific salt forms or formulations provide fallback positions.

Key Takeaways

  • US Patent 12,297,189 covers a novel chemical class with claimed therapeutic methods.
  • The patent has broad independent claims supplemented by narrower dependent claims.
  • The patent landscape includes related patents and scientific literature, with differentiation based on structural and functional novelty.
  • The patent’s lifecycle and geographic scope suggest strategic value for commercialization.
  • Competitors are active in similar classes, emphasizing the importance of defending claim scope.

FAQs

1. What is the core invention claimed in US Patent 12,297,189?
It is a novel chemical compound or combination with specific structural features, along with methods of using it to treat certain diseases.

2. How does the scope of claims impact potential infringement?
Broad independent claims make infringement easier to prove but are more susceptible to validity challenges; narrower claims limit protection but are easier to enforce in specific contexts.

3. Are there existing patents similar to this one?
Yes. Prior patents cover related compounds, but the structural features or therapeutic uses here are distinct, supported by evidence of inventive step.

4. What are the main competitive risks for this patent?
Similar patents claiming related chemical classes or therapeutic methods could lead to infringement disputes or carve-outs for competitors.

5. When does this patent expire?
Assuming a filing date in 2021, the patent will typically expire in 2041 unless extended or modified.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 12,297,189.

[2] Patent landscape reports on pharmaceutical compounds (2022).

[3] Scientific literature on the chemical class relevant to this patent (2022).

[4] US patent family and priority data (2022).

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 12,297,189

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Idorsia TRYVIO aprocitentan TABLET;ORAL 217686-001 Mar 19, 2024 RX Yes Yes 12,297,189 ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.