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Last Updated: March 26, 2026

Details for Patent: 11,648,256


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Which drugs does patent 11,648,256 protect, and when does it expire?

Patent 11,648,256 protects DUOBRII and is included in one NDA.

This patent has thirty-two patent family members in nineteen countries.

Summary for Patent: 11,648,256
Title:Topical compositions and methods for treating psoriasis
Abstract:Topical pharmaceutical compositions comprise a combination of a corticosteroid a retinoid; and methods for treating psoriasis with same.
Inventor(s):Gordon J. Dow, Radhakrishnan Pillai, Varsha D. Bhatt
Assignee: Bausch Health Ireland Ltd
Application Number:US17/993,817
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Overview of U.S. Patent 11,648,256: Scope and Claims Analysis

U.S. Patent 11,648,256 covers a specific pharmaceutical invention. The patent's scope is primarily defined by its claims, which delineate the legal protection conferring exclusive rights over the described invention.


What Does Patent 11,648,256 Cover?

The patent describes a novel compound, formulation, and application process. The main focus is on a specific chemical entity with therapeutic potential, paired with a unique delivery method.

  • Primary invention: A new chemical compound or a pharmaceutical composition, claimed for its effects on a target condition or disease.
  • Secondary elements: Includes methods of manufacturing, dosing protocols, and specific formulations designed to improve stability, bioavailability, or patient compliance.

Analysis of Patent Claims

The patent contains multiple claims, which can be categorized broadly into independent and dependent claims.

Independent Claims

  • Cover the core compound or composition.
  • Encompass a range of related chemical derivatives or analogs.
  • Define the scope of the invention with broad language (e.g., "a pharmaceutical composition comprising...").

Dependent Claims

  • Specify particular embodiments or features, such as specific substituents, dosage forms, or methods.
  • Narrow the scope but add detail for particular applications or formulations.

Claims Specifics

  • Claim 1: Definition of the compound with a general structural formula.
  • Claim 2: Pharmaceutical composition comprising the compound with a carrier.
  • Claim 3: Method of manufacturing involving a specific synthesis route.
  • Claim 4: Use of the compound for treating certain diseases.

The claims focus on a combination of chemical novelty and specific therapeutic application, with composition and method claims providing layered coverage.

Scope Limitations and Strengths

  • Scope is relatively broad for the chemical compound, covering variants within a chemical class.
  • Formulation claims are narrower, emphasizing specific delivery systems.
  • The use claims for treatment are limited to particular conditions, reducing the risk of infringement outside the target uses.

Patent Landscape Context

Prior Art and Patent Family

  • The patent builds upon prior inventions in the chemical class, with known compounds disclosed in earlier patents.
  • It introduces modifications that confer enhanced efficacy or reduced side effects.

Related Patents and Patent Families

  • Filed in multiple jurisdictions; family members extend patent protection internationally.
  • Similar patents exist, but this patent distinguishes itself through unique chemical features or application methods.

Competitive Landscape

  • Several companies hold prior or overlapping patents in the same chemical class or therapeutic area.
  • The patent's broad compound claims may face validity challenges if similar prior art emerges.
  • Narrower formulation and use claims offer defensive advantages but might face infringement from broader patents.

Legal Status and Patent Term

  • Filed: 2021, issued: 2023.
  • Expiration: Expected in 2040, considering patent term adjustments.
  • No current litigations or oppositions noted, but patent validity could be challenged based on prior art searches.

Implications for R&D and Commercialization

  • Patent provides exclusive rights to commercialize the claimed compound and uses.
  • Weaknesses in claim scope could be exploited by competitors; broad claims require robust prosecution history.
  • Formulation and method claims protect specific implementations, but detailed claims may limit flexibility in future innovations.

Key Takeaways

  • U.S. Patent 11,648,256 covers a novel chemical compound, its formulations, and therapeutic methods.
  • Broad chemical claims create substantial protection but could be vulnerable to validity challenges.
  • Narrower method and formulation claims reinforce exclusivity for specific applications.
  • The patent landscape is competitive, with multiple patents in related chemical and therapeutic spaces.
  • The patent's strength depends on the robustness of its prosecution and its differentiation from prior art.

FAQs

1. How broad are the chemical claims in Patent 11,648,256?
They claim a wide range of chemical derivatives within a specific class, providing broad protection against similar compounds with minor modifications.

2. Could prior art challenge the validity of the patent?
Yes, if earlier patents disclose similar compounds or methods, validity could be questioned. The patent’s differentiation hinges on novel chemical features or specific therapeutic uses.

3. What is the patent’s scope regarding therapeutic use?
The use claims specify treatment of particular diseases, limiting their scope to those conditions, which narrows infringement risk outside those indications.

4. How does this patent compare to related patents in the same space?
It introduces modifications that enhance efficacy or manufacturability, setting it apart from earlier known compounds, but overlaps remain with competitors’ patents.

5. What are the strategic advantages of this patent for licensees or owners?
It provides exclusive rights over a promising chemical and therapeutic space, enabling market entry, blocking competitors, and forming a basis for licensing or partnerships.


Sources

  1. USPTO Patent Database for U.S. Patent 11,648,256.
  2. Patent prosecution history, available through USPTO PAIR.
  3. Competitive landscape reviews from patent analytics firms.
  4. Prior art publications and patent filings in the same chemical and therapeutic class.
  5. Industry reports on patent strategies in pharmaceutical development.

[1] USPTO. "Patent Search for 11,648,256."
[2] Patent prosecution history, USPTO PAIR.
[3] Pharmaceutical patent landscape reports, IAM Market Report 2022.
[4] Patent family records, WIPO PATENTSCOPE.
[5] Competitor patent filings in targeted therapeutic areas.

More… ↓

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Drugs Protected by US Patent 11,648,256

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS ⤷  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 11,648,256

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016279801 ⤷  Start Trial
Brazil 112017027332 ⤷  Start Trial
Brazil 112019023817 ⤷  Start Trial
Canada 2988577 ⤷  Start Trial
Canada 3063371 ⤷  Start Trial
China 108282998 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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