Scilex is initiating a legal case against Apotex to protect its lidocaine patch from a potential competitor. According to reports, when the blank-check company Vickers Vantage Corp agreed to merge with Scilex, it identified the pain patch ZTlido as a key motivator for the deal.
Reportedly, Apotex filed an abbreviated new drug application for a generic copy of ZTlido on May 10, around six months after Scilex and Vickers disclosed their proposed merger.
According to Scilex, Apotex’s approval filing infringes three valid ZTlido patents and it describe a non-aqueous patch comprising lidocaine and other ingredients. According to reports, the company is expecting to compete with generic lidocaine patches manufactured by Mylan, Teva Pharmaceutical Industries, and Par Pharmaceutical as well as with the branded Lidoderm. However, those patches use aqueous bases, giving Scilex the chance to differentiate its product.
“If we are unable to maintain patent protection for ZTlido and our product candidates, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets,” Scilex wrote.
Scilex claims that the competition will be limited to generic Lidoderm patches. Moreover, other products are forecast to render ZTlido a small part of Scilex’s sales mix, but at present it is the key product. Meanwhile, Apotex’s filing threatens Scilex’s ability to hit its sales targets, as the company explained in a financial filing.