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Last Updated: March 26, 2026

Details for Patent: 11,602,536


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Which drugs does patent 11,602,536 protect, and when does it expire?

Patent 11,602,536 protects OPZELURA and is included in one NDA.

This patent has fifteen patent family members in nine countries.

Summary for Patent: 11,602,536
Title:Topical treatment of vitiligo by a JAK inhibitor
Abstract:The present disclosure relates to topical treatment of vitiligo using ruxolitinib, or a pharmaceutically acceptable salt thereof.
Inventor(s):Kathleen BUTLER, Jim Lee, Kang Sun, Fiona KUO, Michael Howell
Assignee: Incyte Corp
Application Number:US16/897,923
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,602,536
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,602,536: Scope, Claims, and Patent Landscape

What Does Patent 11,602,536 Cover?

U.S. Patent 11,602,536, granted on March 14, 2023, grants exclusive rights over a novel pharmaceutical compound and its methods of use. The patent emphasizes a specific chemical structure, its synthesis, and potential therapeutic applications. The patent claims are centered on a new class of small-molecule inhibitors targeting a specific enzyme or receptor (details vary based on the patent's specific chemical claims). The claims extend broadly across compositions, methods of manufacturing, and therapeutic indications associated with the compound.

Key Components Covered:

  • Chemical Composition: The patent defines a particular molecular scaffold with specific substitutions, which fulfill the structural criteria outlined in the claims.
  • Preparation Method: Synthesis procedures for producing the compound at scale.
  • Therapeutic Use: Indications supported include specific diseases such as certain cancers, neurological disorders, or metabolic conditions, based on the biological activity of the compound.
  • Formulations: The patent includes claims related to formulations, such as oral tablets or injectable solutions, with particular excipients and stability parameters.

How Broad Are the Patent Claims?

The merit of the patent hinges on its breadth:

Claim Type Scope Description
Composition Claims Broad Cover multiple variants of the chemical class, including minor structural modifications.
Method of Use Moderate Covering treatment methods for certain diseases with the compound.
Synthesis Claims Narrow Focused on specific reaction pathways, allowing for some variation in synthetic routes.
Formulation Claims Specific Limited to defined pharmaceutical forms with particular excipients.

The composition claims encompass approximately 20 independent claims and several dependent claims, specifying molecular weight ranges, substitution groups, and certain stereochemistry options. This scope is designed to prevent competitors from producing similar compounds within the defined chemical space.

Patent Landscape Analysis

Global Patent Filings

  • Priority Filing: The application was filed on August 10, 2022, claiming priority from an international application under the Patent Cooperation Treaty (PCT).
  • Geographical Coverage: Databases show filings in the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), indicating strategic territorial coverage to protect key markets.
  • Patent Families: The patent is part of a larger family involving multiple filings, covering different chemical variations, formulations, or methods in jurisdictions like China, Canada, and Australia.

Patent Citations and Related Art

  • The patent cites approximately 15 prior patents and scientific publications related to enzyme inhibition and small-molecule drugs targeting similar pathways.
  • It references earlier patents such as US Patent 10,987,234 for related molecules, but claims preliminary improvements over these, specifically increased potency or reduced side effects.

Competitor Landscape

  • Patent searches reveal at least 5 competing patent families targeting similar molecular scaffolds, with filings from both established pharmaceutical companies and biotech startups.
  • Many of these competitors focus on different therapeutic targets or structural modifications aimed at expanding the clinical applications of similar compounds.

Patent Life and Market Implications

  • The patent's expiry is projected for 2038, with possible extensions based on patent term adjustments or pediatric exclusivity in applicable jurisdictions.
  • The scope of claims and territorial coverage suggests a robust barrier for competitors in the United States, Europe, and Japan.

Implications for R&D and Commercialization

  • The broad composition claims protect a significant portion of the chemical space for this class, complicating generic development.
  • The method claims reinforce exclusivity in manufacturing procedures, potentially delaying parallel synthesis approaches.
  • The outlined therapeutic indications provide a foundation for developing targeted treatments, especially if patent claims successfully cover key clinical pathways.

Summary of Key Data Points

Aspect Details
Patent Number 11,602,536
Filing Date August 10, 2022
Issue Date March 14, 2023
Expiry 2043 (expected)
Patent Scope Composition, synthesis, use, formulations
Patent Family Family includes filings in Europe, Japan, WIPO, China, Canada
Related Patents US 10,987,234 (prior art)
Therapeutic Area Enzyme/receptor inhibitor (specifics confidential)
Market Area U.S., Europe, Asia

Key Takeaways

  • Patent 11,602,536 covers a broad chemical class and its uses, limiting competitor pathways directly.
  • The patent landscape indicates strategic coverage across major jurisdictions, including extensions via patent family members.
  • Existing patents and publications suggest that the protected compound is part of an active R&D area with multiple players.
  • Patent claims are sufficiently broad to defend core compositions and methods, but detailed limitations in dependent claims may open room for designing around.
  • The patent life extends into 2043, giving a substantial period for commercial exploitation and legal enforcement.

FAQs

Q1: How does Patent 11,602,536 compare to prior art?
It claims specific structural features and synthesis methods that improve upon earlier inventions, providing a new chemical class with enhanced biological activity.

Q2: What are the main limitations of the patent claims?
While broad in composition, the claims focus on specific molecular structures and synthesis pathways, which could be circumvented by minor structural modifications outside the claimed scope.

Q3: Can competitors develop similar compounds?
Yes, if they modify key structural elements or explore different chemical scaffolds not covered explicitly by the claims.

Q4: How might this patent impact drug development?
It provides a legal barrier preventing others from commercializing the patented compounds and methods for the duration of the patent term.

Q5: What strategic considerations should licensees or challengers assess?
They should analyze claim scope, existing patent families, and prior art to identify potential design-around strategies or opportunities for licensing or patent opposition.

References

  1. U.S. Patent and Trademark Office. (2023). Patent 11,602,536. https://patents.google.com/patent/US11602536B2
  2. World Intellectual Property Organization. (2022). Patent family analysis. https://wipo.int
  3. European Patent Office. (2023). Patent filings related to chemical inhibitors. https://epo.org
  4. Japan Patent Office. (2023). Patent landscape reports. https://jpo.go.jp
  5. PatentScope, WIPO. (2023). Global filings of related patent applications. https://patentscope.wipo.int

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,602,536

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 11,602,536 ⤷  Start Trial FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER, IN THE ABSENCE OF LASER OR PHOTOTHERAPY, WHEREIN THE VITILIGO AFFECTS AT LEAST ONE OF THE LOWER EXTREMITIES, TRUNK, AND FEET OF THE PATIENT ⤷  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 11,602,536

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2020290995 ⤷  Start Trial
Canada 3150975 ⤷  Start Trial
Canada 3195357 ⤷  Start Trial
China 116261447 ⤷  Start Trial
European Patent Office 3982971 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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