USPTO allowance covers Sofdra drug substance technology
Botanix Pharmaceuticals Limited said the United States Patent and Trademark Office has issued a Notice of Allowance for a new US patent application linked to Sofdra, its FDA-approved treatment for primary axillary hyperhidrosis.
The application is US patent application Serial No.
Once issued, the patent is expected to add to existing US protections against unauthorised commercial manufacturing of Sofdra’s drug substance into May 2040.
Sofdra contains sofpironium and has FDA approval for adults and paediatric patients aged nine and older with primary axillary hyperhidrosis.
Serial No. 17/611,158
According to Botanix, the allowed claims cover proprietary aspects of the sofpironium drug substance technology used in Sofdra’s commercial manufacture.
In this filing, the crystalline form of sofpironium bromide is the chemical entity being protected. Botanix said that type of patent is usually harder to design around.
Dr Howie McKibbon, Botanix chief executive officer, said strengthening the company’s intellectual property estate around Sofdra remained a strategic priority.
He added that the Notice of Allowance further expands Botanix’s US patent portfolio and supports Sofdra’s long-term commercial opportunity out to 2040.
Multiple issued patents running to 2040 would give Sofdra a long period of market exclusivity, according to Botanix. As a result, the company expects support for long-term revenue and greater appeal in licensing or partnership deals.
Philadelphia and Phoenix base
Botanix Pharmaceuticals Limited trades on the ASX under the code BOT and is based in Philadelphia and Phoenix in the United States.
The allowance adds to Botanix’s broader US patent portfolio around Sofdra, which is its lead commercial product.
Meanwhile, the company said it is continuing to build out its US dermatology offering while protecting the innovations behind Sofdra.
Because the filing covers drug substance technology used in manufacturing, it targets more than the finished branded treatment.
Protection over the underlying chemical form can create a stronger barrier to unauthorised commercial manufacturing in the US market.
Following issuance, the expected May 2040 protection date would extend Botanix’s patent position around Sofdra in the United States.
