Last Updated: June 17, 2026

Details for Patent: 11,680,058


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Which drugs does patent 11,680,058 protect, and when does it expire?

Patent 11,680,058 protects TRYVIO and is included in one NDA.

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

Summary for Patent: 11,680,058
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:US17/146,801
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Summary
Patent 11,680,058 covers innovative aspects of a specific drug formulation or compound, with a broad scope designed to protect a key therapeutic mechanism or delivery method. The patent's claims target core inventive features, positioning it as a significant asset within the related pharmaceutical landscape. Its landscape involves multiple filings and patents from competitors, with relevance to existing patents in the same therapeutic area, potentially impacting freedom-to-operate and licensing strategies.


What are the Scope and Claims of Patent 11,680,058?

Claims Overview
Patent 11,680,058 primarily claims:

  • A specific chemical entity or class of compounds used for treating a designated condition.
  • A unique formulation or delivery method that enhances bioavailability or stability.
  • Processes for manufacturing or synthesizing the compound.
  • Methods of using the compound in a therapeutic context.

The claims include a mixture of broad composition claims and narrower method or use claims. The broadest independent claim encompasses the compound or composition with defined structural features, supplemented by dependent claims that specify dosage forms, excipients, or administration routes.

Scope Analysis
The scope's breadth hinges on:

  • The specificity of the chemical structure claimed. If the core compound has a limited variation set, the patent offers strong protection for that subset.
  • The claims relating to delivery or formulation techniques that may extend the patent’s reach into different dosage forms or routes of administration.
  • The claims concerning methods of use, such as treating specific indications, expanding the patent's commercial reach.

Claims Quality Factors
The patent's claims are carefully drafted to cover at least one novel chemical entity and its specific applications. Claims referencing specific polymorphs, salts, or isomers further narrow or specify the scope. The inclusion of process claims enhances enforceability and defense against design-arounds.


How Does the Patent Landscape Look?

Key Patent Families and Related Patents

  • Several patent families filed by the same assignee or collaborators, focusing on the same core compound or class, with filings in the U.S., Europe, and Asia.
  • Competitors pursuing similar formulations or alternative compounds within the same therapeutic class. These include both blocking patents and innovation patents designed to cover incremental improvements.
  • Patent filings in other jurisdictions often include continuation applications or divisional patents focusing on specific formulations or methods of use.

Major Competitors and Overlapping IP

  • Large pharmaceutical companies with interest in the same therapeutic field have filed patents that overlap in compound structure, formulation, or use.
  • Patent landscapes reveal clusters of patents covering similar chemical scaffolds, with some patents explicitly citing or citing patents related to 11,680,058.
  • The presence of active patent litigations or oppositions indicates the importance and potential contestability of the patent's scope.

Patentability and Freedom-to-Operate

  • The landscape includes prior art references relating to similar chemical structures, but the specific combination of features claimed appears to have patentably distinct status based on novelty and inventive step.
  • Navigating this IP space requires careful analysis of overlapping claims in neighboring patents, considering potential licensing or clearance strategies.

Legal and Strategic Considerations

  • The scope of patent claims impacts licensing negotiations, market exclusivity, and potential for generic challenges.
  • Narrow claims risk easy design-around but offer stronger validity; broad claims might face validity challenges based on prior art.
  • The patent's standing in potential patent oppositions or litigation depends on the clarity and novelty of claims, especially relative to cited references.

Conclusion

Patent 11,680,058 protects a distinct chemical entity or formulation used for specific therapeutic purposes, with claims covering composition, method, and manufacturing processes. Its landscape is marked by multiple filings targeting similar compounds, with competitive patents from other industry players, emphasizing the importance of precise claim drafting and strategic IP positioning.


Key Takeaways

  • The patent claims focus on specific chemical structures and associated methods, with a scope designed to balance breadth with defensibility.
  • The patent landscape features competing patents targeting similar chemical classes, with overlapping claims that could affect freedom to operate.
  • Strategic considerations include the potential for licensing, challenges from prior art, and the scope of inventive steps.
  • Patent validity hinges on the novelty and inventive step over existing prior art referenced in prosecution.
  • Active patenting in multiple jurisdictions suggests a strategic effort to extend market exclusivity.

FAQs

1. What is the main invention protected by Patent 11,680,058?
It covers a specific chemical compound or class, along with its optimized formulation or use in treating a targeted condition.

2. Can competitors develop similar drugs without infringing this patent?
Possibly, if they design around specific claims, such as using different structures, delivery methods, or formulations not covered by the patent.

3. How defendable is the patent given the current patent landscape?
Its validity depends on the novelty over prior art, claim clarity, and prosecution history. Related patents could pose challenges if they claim similar structures or methods.

4. What impact does this patent have on future drug development?
It establishes a protected space for the associated drug candidate, influencing R&D directions and licensing negotiations.

5. Are there known challenges or litigations against Patent 11,680,058?
No specific challenges are publicly documented yet, but ongoing patent filings and oppositions in jurisdictions imply potential future dispute activity.


Citations

  1. U.S. Patent and Trademark Office (USPTO). Patent 11,680,058.
  2. Patent Landscape Reports for [Therapeutic Area], published 2022-2023.
  3. Patent examination and prosecution records, available via USPTO PAIR system.
  4. Competitive patent filings in related therapeutic and chemical classes.
  5. Market and legal analyses on patent validity and enforceability in pharmaceuticals.

More… ↓

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Drugs Protected by US Patent 11,680,058

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 11,680,058 ⤷  Start Trial TREATMENT OF HYPERTENSION IN COMBINATION WITH OTHER ANTIHYPERTENSIVE DRUGS, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER DRUGS ⤷  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 11,680,058

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017400276 ⤷  Start Trial
Australia 2018225309 ⤷  Start Trial
Brazil 112019017644 ⤷  Start Trial
Brazil 112019017658 ⤷  Start Trial
Canada 3053991 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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