- A U.S. district court in New Jersey on Friday invalidated Johnson & Johnson's sole unexpired patent for Zytiga, putting the blockbuster cancer drug at risk of imminent generic competition.
- J&J subsidiary Janssen Pharmaceuticals "strongly disagrees with the court's ruling and will continue to defend the patent," according to an Oct. 26 statement. The company said it plans to appeal the decision.
- The deciding judge forbade any generic launches through Oct. 30 as the court weighs a preliminary injunction motion from Janssen to push off generic entry until the appeals process runs its course.
J&J executives, while reiterating faith in the company's patent claims for Zytiga, spent the most recent earnings call emphasizing how the drug was not essential to future growth.
On the Oct. 16 earnings call, J&J's worldwide chair of pharmaceuticals Jennifer Taubert said the company is "absolutely not dependent" on Zytiga.
Taubert remarked that third quarter growth would be 6.6% if Zytiga was completely removed from the calculations, emphasizing the growing role of other J&J drugs such as Tremfya (guselkumab) and Stelara (ustekinumab).
Since approval in 2011, Zytiga has grown into a profitable asset for J&J, posting $1.4 billion in U.S. sales for the first nine months of 2018. Last year, the drug raked in more than $2.5 billion in worldwide sales. Internationally, Janssen says regulatory exclusivity protects Zytiga through September 2022.
This court challenge threatens the only active patent listed in n the Orange Book for Zytiga, known as the '438 patent. The patent is set to expire in 2027, but the invalidation could open the market to generic competition much sooner than that.
Previously, the Patent Trial and Appeal Board ruled in January the '438 patent was obvious and therefore unpatentable.
Markets, however, didn't react much. J&J shares ended Monday trading essentially flat from Friday's close.
Generic competitors, meanwhile, are lining up to fight for any share of Zytiga's market. Companies such as Teva Pharmaceuticals and Mylan are among the competitors challenging the patent in court.
J&J has settled with Glenmark and Apotex, while Sun Pharma has withdrawn its application.
Regardless of when, or if, Zytiga goes generic, the broader therapeutic area is already contested by Pfizer and Astellas Pharma's Xtandi (enzalutamide), which became the first and only medication approved in the U.S. this July for both metastatic and non-metastatic castration-resistant prostate cancer.
For its part, Janssen has rolled out what it hopes will be its own successor to Zytiga in Erleada (apalutamide). The Food and Drug Administration approved the drug for certain types of prostate cancer in February.
In the meantime, J&J will try to hold off generic entry on Zytiga as long as possible. In a statement, the company warned that any generic launch would be considered an "at risk launch" by the company, meaning such a competitor could face potential legal action.