J&J hit with patent loss on Zytiga, opening up generics market
There are a number of companies looking to launch generic versions of the prostate cancer treatment, including Teva, Mylan, and Argentum Pharmaceuticals.
The latter challenged the validity of Zytiga (abiraterone acetate)’s patents through the US Patent and Trademark Office and was successful in overturning the drug’s protection through to August 24, 2027.
In the company’s latest setback, Johnson & Johnson (J&J)’s product could now face generic launches as of tomorrow, after the court ordered for the status quo to be maintained until October 31, 2018.
J&J plans to appeal the decision and noted that any decision to launch a generic rival would be considered an “at-risk launch”.
The company additionally stated it “strongly disagrees with the court’s ruling and will continue to defend the patent.”
One of the reasons this will be a particular blow to J&J is the level of growth the product has experienced this year. In third quarter financials, Zytiga’s worldwide sales grew by 57.1%, up to $958m (€842.9m) in this quarter alone.
Overall, its oncology portfolio was a major driver of sales for the company in the US and the product was a cornerstone of this, displaying growth of 71% in the three quarters in this market to-date.
However, the company reiterated it does not expect its operational sales growth of 5.5% to 6% nor its adjusted earning per share guidance to be impacted for the full-year 2018.
Zytiga will still hold patent protection in Europe until September 2022, the company noted.