European Intention to Grant on applicator patent makes Sofdra® more attractive for ex-US commercialization

The bottle design and applicator are an important component of Sofdra®.

The decision strengthens Botanix's European IP position & is expected to enhance the Company's value proposition for potential ex-US commercialization pathways

Botanix Pharmaceuticals Limited (ASX:BOT)

... physicians have told us that the applicator, which helps limit unwanted drug contact to the hands, is one of the key reasons they prescribe Sofdra.”

— Dr Howie McKibbon, Chief Executive Officer of Botanix

PHOENIX, AZ, UNITED STATES, July 7, 2026 /EINPresswire.com/ -- Botanix Pharmaceuticals Limited (ASX:BOT, "Botanix" or "the Company") announces that the European Patent Office ("EPO") has issued an Intention to Grant for European patent application EP 19799730.7, ‘Applicator and System for Pharmaceutical Preparation and Method of Use.’ The application covers proprietary applicator technology used with sofpironium topical gel, 12.45%, the drug product branded as Sofdra^® in the United States.

The patent application covers commercially relevant aspects of the applicator device, including features designed to support controlled topical administration and patient use. Following completion of the formal grant process and validation in selected European countries, protection is expected to extend into May 2039.

Sofdra^® is currently only commercialized in the US. Securing patent protection in Europe before commercializing there is a forward-looking, strategic move. Botanix is proactively securing the IP runway needed to enhance the Botanix value proposition for potential ex-US commercialization.

Dr Howie McKibbon, Chief Executive Officer of Botanix, welcomed the decision, noting it further strengthens the Company's intellectual property estate surrounding the delivery and administration of sofpironium topical gel. He added that physicians have identified the applicator, which helps limit unwanted drug contact to the hands, as one of the key reasons they prescribe Sofdra^®.

Jane Morgan
Investor and Media Relations
info@janemorganmanagement.com.au
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