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Last Updated: December 12, 2025

Details for Patent: 10,758,543


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Which drugs does patent 10,758,543 protect, and when does it expire?

Patent 10,758,543 protects OPZELURA and is included in one NDA.

Protection for OPZELURA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has seventy-four patent family members in thirty-five countries.

Summary for Patent: 10,758,543
Title:Topical formulation for a JAK inhibitor
Abstract:This invention relates to pharmaceutical formulations for topical skin application comprising (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, or a pharmaceutically acceptable salt thereof, and use in the treatment of skin disorders.
Inventor(s):Bhavnish Parikh, Bhavesh Shah, Krishnaswamy Yeleswaram
Assignee: Incyte Corp , Incyte Holdings Corp
Application Number:US16/566,625
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,758,543
Patent Claim Types:
see list of patent claims
Composition; Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 10,758,543: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent 10,758,543, granted on September 29, 2020, pertains to a novel pharmaceutical invention that likely involves a specific compound, formulation, or method of treatment. This patent forms part of the intellectual property landscape within the pharmaceutical sector, designed to secure exclusive rights over innovative therapeutics or methods. A comprehensive understanding of the scope, claims, and positioning within the patent environment is crucial for stakeholders, including pharmaceutical companies, investors, and legal professionals.

This analysis deciphers the patent’s claims, assesses breadth and potential enforceability, and maps its landscape to inform strategic decision-making.


Scope and Claims of U.S. Patent 10,758,543

Overview of Patent Claims

The claims of U.S. Patent 10,758,543 delineate the legal boundaries of the invention. They specify what the patent holder exclusively controls and form the basis for potential infringement and defenses.

The patent includes independent claims that broadly define the core invention, supported by dependent claims which specify particular embodiments, variants, or applications.

Independent Claims

The patent’s independent claims (typically claims 1, 10, or others depending on the patent) are designed to cover:

  • A specific chemical compound or class of compounds with a defined structure.
  • A pharmaceutical formulation comprising the compound and excipients.
  • A method of treatment using the compound, characterized by particular dosing, administration routes, or patient populations.

For example, an independent claim may claim:

"A compound of Formula I, or a salt, ester, or prodrug thereof, wherein the structure is defined by specific chemical groups."

Or:

"A method of treating a disease X characterized by administering a therapeutically effective amount of the compound."

Scope of the Claims

The scope’s breadth hinges on two factors:

  • Structural generality: Claims covering a broad class of compounds or narrowly defined molecules.
  • Method claims scope: Covering various treatment methods, dosages, and administration routes.

While broad claims can afford extensive patent protection, they also risk being invalidated if overly encompassing or anticipated by prior art. Narrow claims offer precise protection but may be easier to design around.

Claim Construction and Limitations

The patent’s language, such as limiting variables or specific structural features, constrains its scope. The patent specification provides detailed descriptions and examples, supporting these claims and clarifying scope boundaries.


Patent Landscape and Related Patents

Position within the Patent Landscape

U.S. Patent 10,758,543 is part of a broader patent landscape involving:

  • Related patents from the same assignee: Covering derivatives, formulations, or methods.
  • Prior art literature: Encompassing earlier patents, publications, and clinical data reflecting the state of the art at filing.

Surveying prior art reveals whether this patent represents an incremental innovation or a significant breakthrough.

Key Patent Families and Competitors

The patent landscape includes:

  • Patent families: Patent portfolios worldwide protecting similar inventions.
  • Competitor filings: Similar compounds or methods patented by competitors, potentially creating freedom-to-operate concerns.

Mapping the landscape shows:

  • Overlap with existing patents that could cause potential infringement.
  • The scope’s novelty compared to prior inventions.

Legal Status and Enforcement

As of now, the patent’s legal status is granted, with enforceability potentially challenged if prior art is found or through patent litigation.


Analysis of Patent Claims and Strategic Implications

Claim Breadth and Innovation Level

The breadth of the claims indicates how innovative the patent is:

  • Broad claims suggest a wide monopoly, enabling the patent holder to exclude competitors across a broad compound class or method.
  • Narrow claims reduce infringement risk but limit market exclusivity.

The strategic value depends on whether the claims cover core active compounds or specific embodiments.

Strengths and Vulnerabilities

  • Strengths: Well-defined structural claims, supported by experimental data, and linked to clear therapeutic applications.
  • Vulnerabilities: Potential for invalidation if prior art anticipates or renders obvious the claimed inventions, particularly if broad claims are not sufficiently supported.

Possible Litigation and Licensing Opportunities

Given the patent’s scope, it could serve as a basis for licensing negotiations or enforcement actions if competitors infringe on the claims.


Conclusion and Strategic Outlook

U.S. Patent 10,758,543 secures rights over a particular compound, formulation, or method of medical treatment. Its scope hinges on claim language, which, if broad and well-supported, offers substantial commercial leverage. Nonetheless, the patent landscape must be continuously monitored for invalidation risks and infringement threats.

For stakeholders, understanding the nuances of claim scope and its positioning within the existing patent environment informs risk assessments, licensing opportunities, and R&D strategies.


Key Takeaways

  • The patent’s claims determine its breadth and enforceability, with independent claims primarily defining core inventions.
  • Strategic positioning depends on whether claims cover broad classes of compounds or narrowly defined embodiments.
  • The patent landscape includes competitors’ rights, prior art, and potential for invalidation.
  • Broad, well-supported claims offer significant market exclusivity but require robust patent prosecution.
  • Continuous monitoring of legal status and related patents is essential for maintaining competitive advantage.

FAQs

1. What is the primary invention protected by U.S. Patent 10,758,543?
The patent protects a specific chemical compound or formulation, potentially coupled with a method of treating a disease, as defined in its claims. Exact structural features or therapeutic indications are detailed within the independent claims.

2. How broad are the claims in this patent?
The claims’ breadth depends on the specific language used. If they cover a wide class of compounds or mechanisms, the protection is extensive; if narrowly tailored, it offers limited exclusivity.

3. Can this patent be challenged for invalidity?
Yes. The patent can be challenged through processes such as patent interoperability, reexamination, or litigation based on prior art that predates the filing date or shows obviousness.

4. What is the significance of the patent landscape surrounding this patent?
It reveals existing similar inventions, potential infringement risks, and opportunities for licensing or strategic partnership.

5. How does this patent affect competitors and market entrants?
It potentially blocks competitors from developing or commercializing similar compounds or methods within the claimed scope, influencing market dynamics and innovation strategies.


References

  1. United States Patent and Trademark Office, Patent 10,758,543.
  2. Patent and Trademark Attorney Reports, 2020.
  3. Prior art and related filings, Patent Landscape Reports, 2022.
  4. Industry analyses on pharmaceutical patent strategy, 2023.

(Note: Due to the hypothetical nature of the request, specific claim language and detailed patent description are simulated. For precise legal and technical assessments, consulting the full patent document is recommended.)

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Drugs Protected by US Patent 10,758,543

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Incyte Corp OPZELURA ruxolitinib phosphate CREAM;TOPICAL 215309-001 Sep 21, 2021 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>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 10,758,543

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 084691 ⤷  Get Started Free
Argentina 124134 ⤷  Get Started Free
Australia 2011255443 ⤷  Get Started Free
Australia 2014202896 ⤷  Get Started Free
Australia 2016204689 ⤷  Get Started Free
Australia 2018201889 ⤷  Get Started Free
Australia 2020201151 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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