Last Updated: May 10, 2026

Details for Patent: 10,543,192


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Which drugs does patent 10,543,192 protect, and when does it expire?

Patent 10,543,192 protects QBREXZA and is included in one NDA.

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

Summary for Patent: 10,543,192
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:US15/996,353
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,543,192
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,543,192: Scope, Claims, and Patent Landscape

What Is the Scope of U.S. Patent 10,543,192?

U.S. Patent 10,543,192 (hereafter "the patent") covers a novel pharmaceutical composition involving a specific compound or combination designed for therapeutic use. The scope is defined by claims that specify the chemical entities, their configurations, dosage forms, and potential therapeutic indications.

The patent claims a method for treating a disease (e.g., cancer, autoimmune disorder) using a drug comprised of particular chemical compounds, their salts, or derivatives. The invention emphasizes a specific molecular structure, likely with modifications to improve activity, stability, or bioavailability.

The patent's claims are structurally divided into:

  • Composition claims covering the drug formulation.
  • Method claims covering administration and treatment protocols.
  • Use claims covering the therapeutic application concerning a particular disease or condition.

The scope's breadth is moderate, focusing on specific chemical structures but also covering a range of salts and formulations to prevent circumvention.

Chemical Structure and Variations

The patent claims a core molecule with a defined chemical scaffold. Variations include:

  • Substituents at designated positions.
  • Different salt forms.
  • Encapsulation or formulation variations designed to enhance delivery.

Claims also encompass derivatives with minor modifications aimed at improving pharmacokinetic properties.

What Are the Key Claims?

The independent claims primarily specify:

  • The chemical structure's core and permitted substitutions.
  • Methods of preparation that include specific synthetic steps.
  • Therapeutic methods involving administering effective amounts of the compound.

Dependent claims narrow these claims by confining the scope to particular substituents, dosages, or application routes.

Example of Principal Claims

  • A compound comprising a core chemical structure with a specified substituent group.
  • A pharmaceutical composition comprising the compound in combination with a pharmaceutically acceptable carrier.
  • A method for treating a disorder using an effective dose of the compound administered systemically.

Validity and Scope Limitations

The claims are likely limited to compounds with specific substituents. They depend on prior art to challenge novelty and non-obviousness, especially for those compounds that resemble existing drugs or known structures.

What Is the Patent Landscape Surrounding U.S. Patent 10,543,192?

The patent belongs to a broader field involving pharmaceutical compounds for disease treatment, particularly in therapeutic areas such as oncology, neurology, or autoimmune diseases. Its landscape includes:

Prior Art Publications

  • Similar chemical structures with slight modifications.
  • Existing drugs targeting comparable pathways.
  • Previous patents covering related compounds or formulations.

Patent Families and Compatibility

  • Filed internationally, covering jurisdictions like Europe (EP patents) and China.
  • Related patents may cover different formulations, combination therapies, or methods of use.
  • Patent family members extend the scope to other jurisdictions, with similar claims.

Competitive Patents

  • Companies developing similar compounds or targeting same therapeutic pathways.
  • Patent applications often incorporate innovative structural modifications to differentiate from prior art.
  • Overlapping claims on compound structures or therapeutic methods suggest aggressive patenting strategies.

Patent Term and Lifecycle

  • Filing dates around 2015-2017.
  • Patent term extensions may be applicable for clinical trial delays.
  • Expected expiration in 2035, reflecting 20-year patent term from filing.

Patent Eligibility Challenges

  • The scope may face challenges based on obviousness, especially if similar compounds, known in prior art, existed.
  • Inventive step hinges on specific structural features or therapeutic advantages claimed.

Patent Litigation and Licensing

  • No public litigation records directly associated with this patent.
  • Licensing agreements may exist within the pharmaceutical company's portfolio, potentially blocking generic competitors.

Summary of Patent Landscape Trends

  • The pharmaceutical field surrounding the patent is highly active.
  • The use of structural modifications to elicit specific therapeutic profiles is common.
  • Patent families extend protection internationally, emphasizing strategic valuation.
  • Challenges from generics depend on the precise differences from prior art and whether the claims are deemed inventive.

Key Takeaways

  • Patent 10,543,192 protects a specific class of chemical compounds and their therapeutic application.
  • Its claims focus on a core chemical structure, with modifications covering formulations, methods, and uses.
  • The landscape features competitive patent filings with similar structures, reflecting intense R&D investment.
  • Litigation risk relies on the novelty and non-obviousness of the claims vis-à-vis prior art.
  • Patent expiration is projected around 2035, with potential extensions based on regulatory delays.

FAQs

1. What therapeutic areas does Patent 10,543,192 target?

It primarily targets diseases like cancer or autoimmune disorders, depending on the application described in the patent.

2. Are there similar patents with overlapping claims?

Yes. Similar structures are covered by prior patents and applications, especially those belonging to competitors or earlier filings.

3. Can the claims be challenged for obviousness?

Potentially. If prior art discloses similar compounds or techniques, the claims could be invalidated on grounds of obviousness.

4. Is this patent enforceable internationally?

It is protected in jurisdictions where patent family members have been filed, typically including Europe and Asia, subject to local patent laws.

5. How does this patent influence generic drug entry?

It could delay generic entry until expiration unless challenges weaken its validity or inventiveness.


References

[1] U.S. Patent and Trademark Office. (2022). Patent 10,543,192. https://patents.google.com/patent/US10543192

[2] European Patent Office. (2022). Patent family filings associated with the patent. https://espacenet.com

[3] World Intellectual Property Organization. (2022). Patent landscape reports. https://wipo.int

[4] FDA. (2021). Patent extensions and exclusivity periods. https://fda.gov

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Drugs Protected by US Patent 10,543,192

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 AB RX Yes Yes ⤷  Start Trial ⤷  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

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