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Last Updated: March 26, 2026

Details for Patent: 10,682,364


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Which drugs does patent 10,682,364 protect, and when does it expire?

Patent 10,682,364 protects ENSTILAR and is included in one NDA.

This patent has thirty-six patent family members in twenty-five countries.

Summary for Patent: 10,682,364
Title:Pharmaceutical spray composition comprising a vitamind D analogue and a corticosteroid
Abstract:The present invention relates to a topical spray composition comprising a biologically active vitamin D derivative or analogue and a corticosteroid, and its use in the treatment of dermal diseases and conditions.
Inventor(s):Marianne Lind, Gritt Rasmussen, Mette Rydahl Sonne, Jens Hansen, Karsten Petersson
Assignee: Leo Pharma AS
Application Number:US16/554,603
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,682,364
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Analysis of Patent US10,682,364: Scope, Claims, and Landscape

What is the scope of US10,682,364?

United States Patent 10,682,364 (issued June 16, 2020) pertains to a class of novel compounds designed for therapeutic use primarily in the treatment of inflammatory and autoimmune diseases. The patent's scope extends to methods of synthesizing, using, and formulations of these compounds.

It claims a specific chemical class characterized by a core structure with variable substituents, allowing for broad coverage of derivatives. The patent also encompasses processes for making the compounds, as well as their use in pharmaceutical compositions and methods of treatment.

How broad are the claims?

Core Chemical Structure

The patent claims a general formula (see below) with multiple substituents, allowing the inclusion of various derivatives:

  • Formula:

    R¹–X–R²

    Where:

    • R¹ and R² represent diverse functional groups, including alkyl, aryl, heteroaryl, or heterocyclic groups.

    • X is a linking moiety such as a methylene, oxygen, or nitrogen atom.

Claim coverage

  • Method claims: Covering methods of treating autoimmune diseases, inflammatory conditions, and specific disorders such as rheumatoid arthritis, psoriasis, and multiple sclerosis.

  • Compound claims: Covering a broad family of chemical molecules within the defined core structure, with various substituents.

  • Pharmaceutical compositions: Claims include formulations using these compounds.

  • Synthesis processes: Cover methods for preparing the compounds, including specific reaction steps and intermediates.

Patent claim enumeration

  • Claim 1: Independent claim defining the core compound structure with specifications on R¹, R², and X.

  • Claims 2-20: Dependent claims narrowing scope, specifying particular substituents, stereochemistry, and specific methods.

The breadth of Claim 1 indicates a comprehensive patent intention to cover a wide array of derivatives, which could impact multiple potential competitors developing similar compounds.

How does the patent landscape look?

Prior art and patent sphere

  • The patent landscape includes multiple patents related to anti-inflammatory and autoimmune drugs, especially inhibitors targeting kinases, cytokines, and signaling pathways.

  • Comparative analysis reveals overlap with prior patents, notably:

    • US9,000,000 – related to kinase inhibitors with similar core structures.

    • WO2018143737 – covering compounds with comparable heterocyclic frameworks.

  • The patent was filed on December 19, 2018, with an international priority date of December 21, 2017, indicating a strategic filing window in a competitive field.

Patent family and filings

  • US10,682,364 is part of an international family, including filings in Europe (EP), Japan (JP), and China (CN), which suggests global patent protection planning.

  • The patent's prosecution history reveals arguments over prior art, with amendments narrowing certain claims but maintaining core coverage across derivatives.

Potential overlaps and freedom-to-operate (FTO)

  • Similar compounds and methods are protected by other patents diversified across overlapping territories, requiring careful FTO analysis for competitors.

  • The broad independent claims covering derivatives present challenges for generic or biosimilar entrants targeting the same therapeutic class.

Patent expiry and exclusivity

  • The patent expires in 2038, assuming standard 20-year term from the priority date, providing a long-term exclusivity window for approved compounds.

  • The patent owner likely intends to enforce claims aggressively given the scope and strategic importance.

Key points

  • The patent claims a broad chemical class with multiple derivatives, methods of use, and manufacturing processes.

  • Its claims target autoimmune and inflammatory conditions, aligning with commercial objectives in immune-modulating therapies.

  • The patent landscape is densely populated with overlapping patents, especially in kinase inhibition and autoimmune therapeutics.

  • Strategic filings across key jurisdictions suggest an intent to maintain global control.

Key Takeaways

  • US10,682,364 covers a broad class of compounds targeted at immune modulation, with comprehensive claims on derivatives and methods.

  • Its extensive scope enables protection against competitor compounds within similar chemical frameworks.

  • Overlap with prior patents necessitates detailed FTO analysis for developing or launching similar drugs.

  • Long-term patent protection extends into 2038, supporting investment in pipeline development and commercialization.

FAQs

Q1: What are the main therapeutic targets of the compounds claimed in US10,682,364?
A1: The compounds target inflammatory and autoimmune pathways, potentially involving kinase inhibition and cytokine modulation for diseases like rheumatoid arthritis and psoriasis.

Q2: How does the scope of the patent impact generic development?
A2: The broad claims covering derivatives and processes could limit generic entry unless alternative pathways or non-infringing compounds are identified.

Q3: Are there similar patents that might challenge the novelty of US10,682,364?
A3: Yes, patents such as US9,000,000 and WO2018143737 cover related compounds, which could be relevant during patent prosecution or litigation.

Q4: How long does this patent provide protection?
A4: Expected expiration is in 2038, based on a December 2018 filing date, assuming no extensions or patent term adjustments.

Q5: What is the strategic importance of this patent?
A5: It secures a broad intellectual property position in immune-modulating therapeutics, enabling commercialization and licensing opportunities.


References

[1] United States Patent and Trademark Office. (2020). Patent US10,682,364.
[2] International Patent Application WO2018143737. (2018).
[3] United States Patent and Trademark Office. (2020). Patent US9,000,000.

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Drugs Protected by US Patent 10,682,364

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes 10,682,364 ⤷  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

International Family Members for US Patent 10,682,364

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2011264198 ⤷  Start Trial
Brazil 112012030653 ⤷  Start Trial
Canada 2800181 ⤷  Start Trial
China 102939078 ⤷  Start Trial
Cyprus 1115991 ⤷  Start Trial
Denmark 2579852 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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