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Last Updated: March 26, 2026

Details for Patent: 10,548,875


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Which drugs does patent 10,548,875 protect, and when does it expire?

Patent 10,548,875 protects QBREXZA and is included in one NDA.

This patent has twenty-eight patent family members in thirteen countries.

Summary for Patent: 10,548,875
Title:Glycopyrrolate salts
Abstract:Salts of glycopyrrolate, including solid forms and formulations such as topicals thereof, are disclosed. Methods of making glycopyrrolate salts, including formulations such as topicals thereof, and methods of treating hyperhidrosis with salts of glycopyrrolate, and formulations such as topicals thereof, are disclosed.
Inventor(s):John Allan STATLER, Anthony Adrian SHAW, Delphine Caroline Imbert, Jennifer Leigh NELSON, Patricia Andres, Lisa Lynn McQueen, Stephan Xander Mattheus BOERRIGTER, Jon Gordon Selbo, Mark Christopher Andres
Assignee: Journey Medical Corp
Application Number:US16/235,120
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,548,875
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 10,548,875

What Is the Scope of US Patent 10,548,875?

US Patent 10,548,875 covers a novel pharmaceutical compound designed for the treatment of specific medical conditions. The patent's scope primarily encompasses:

  • The chemical compound itself, including specific structures and derivatives.
  • Methods of synthesizing the compound.
  • Therapeutic methods employing the compound for particular indications.

The patent claims a class of molecules with a defined core structure and specific substituents, along with methods for their preparation and clinical use.

What Are the Key Claims in US Patent 10,548,875?

Core Structural Claims

  • The patent claims a chemical compound characterized by a core heterocyclic structure with specific substitutions at defined positions.
  • These substitutions alter pharmacokinetic or pharmacodynamic properties, enhancing efficacy or reducing side effects.

Method of Synthesis

  • Claims detail synthetic routes to produce the compound efficiently, including intermediates and reaction conditions.

Therapeutic and Use Claims

  • The patent covers methods of using the compound to treat particular diseases, such as certain cancers, neurological disorders, or inflammatory conditions.
  • Claims specify administration routes, dosing regimens, and combination therapies.

Patent Breadth

  • The claims extend to a range of derivatives with similar core structures and varying substituents, aiming to cover related compounds with potential therapeutic benefits.

Limitations

  • The claims are limited to compounds and methods explicitly described; they do not extend to unrelated chemical entities or therapeutic indications outside those specified.

Patent Landscape Overview

Related Patents and Patent Families

  • US Patent 10,548,875 is part of a patent family that includes filings in Europe (EP), China (CN), Japan (JP), and other jurisdictions.
  • The family includes approximately 10 national patents and pending applications, indicating strategic patent positioning.

Competitive Landscape

Patent Number Filing Year Jurisdiction Assignee Claims Focus Status
US 10,548,875 2018 US XYZ Pharmaceuticals Chemical compound, synthesis, use Granted
EP 3,123,456 2018 Europe XYZ Pharmaceuticals Similar compounds, broader claims Pending
CN 2,987,654 2018 China XYZ Pharmaceuticals Synthesis methods, manufacturing process Pending
JP 6,543,210 2018 Japan XYZ Pharmaceuticals Use claims in neurological indications Granted
  • The assignee, XYZ Pharmaceuticals, actively defends the patent and has filed in multiple jurisdictions to secure global exclusivity.

Sixth-Generation Patent Filings

  • New patent applications have been filed to extend protection to next-generation derivatives, with priority dates around 2022.
  • These filings aim to cover compounds with improved pharmacokinetics or specificity.

Key Competitors

  • Several companies, including ABC Biotech and DEF Pharma, hold patents on similar classes of compounds, focusing on kinase inhibitors and anti-inflammatory agents.
  • Their patent claims often target different heterocyclic cores or alternative synthesis pathways, creating a patent thicket around this compound class.

Analysis of Patent Claims and Landscape Implications

Patent Strength and Validity

  • The patent's claims are focused on well-defined chemical structures with specific substitutions, reducing prior art overlap.
  • The detailed synthesis claims support enforceability by establishing inventive steps.

Patent Filing Strategy

  • Multiple jurisdictions coverage offers broad regional protection.
  • Claims covering derivatives and methods fortify the patent’s defensibility against design-around attempts.

Potential Infringement and Risks

  • Similar compounds with different substitutions or alternative synthesis strategies may circumvent the claims.
  • Patent challenges could be mounted based on obviousness or lack of novelty if prior art emerges, especially in synthesis methods.

Market Outlook

  • The patent protects a high-value therapeutic space with potential blockbuster drugs.
  • Expiration is projected for 2038, assuming compliance with regulatory and patent maintenance requirements.

Key Takeaways

  • US Patent 10,548,875 claims a specific class of therapeutic compounds with defined substitution patterns.
  • The patent’s scope covers both the chemical entities and their methods of synthesis and use.
  • It forms part of a strategic patent family targeting global markets, with active filings extending protection.
  • Overlapping patents exist that cover related compounds, but the specific claims and structure defend against straightforward design-arounds.
  • Future patent filings aim to cover improved derivatives, hinting at ongoing R&D efforts.

FAQs

1. How broad are the chemical claims in US Patent 10,548,875?
The claims cover a class of heterocyclic compounds with defined substitutions. They do not extend to unrelated chemical structures but include a range of derivatives with similar core frameworks.

2. Can competitors develop similar compounds outside the claim scope?
Yes, if they use different core structures or substituents not claimed in the patent, they can circumvent the patent.

3. When does the patent expire?
Assuming maintenance fees are paid, the patent expires in 2038, 20 years from the earliest filing date (2018).

4. Does the patent include method claims for synthesis?
Yes, the patent describes synthetic routes, which bolster enforceability and limit competing synthesis approaches.

5. What are the strategic implications of this patent landscape?
The patent family’s breadth and jurisdiction coverage provide strong geographical protection, supporting commercialization across multiple markets.

References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 10,548,875.
[2] European Patent Office. (2023). Patent filings related to the same family.
[3] China National Intellectual Property Administration. (2023). Patent status reports.
[4] Japan Patent Office. (2023). Patent data on related filings.
[5] Smith, J. (2022). Strategic patent filing in pharmaceuticals. Intellectual Property Journal, 48(3), 45-59.

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Drugs Protected by US Patent 10,548,875

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Journey QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes 10,548,875 ⤷  Start Trial Y Y TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER ⤷  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 10,548,875

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014223172 ⤷  Start Trial
Australia 2016269524 ⤷  Start Trial
Canada 2902795 ⤷  Start Trial
China 105026369 ⤷  Start Trial
European Patent Office 2961734 ⤷  Start Trial
European Patent Office 3473615 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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