J&J takes Aurobindo to court over potential Erleada generic
Since snagging a first approval in prostate cancer back in 2018, Johnson & Johnson has been working to make Erleada a blockbuster franchise. Now that means fighting off a potential generic from Aurobindo.
A group of plaintiffs, including J&J’s Janssen unit and the Sloan Kettering Institute for Cancer Research, filed a lawsuit against Aurobindo on Thursday accusing it of applying to market an Erleada copycat before five patents are up.
In the complaint, the plaintiffs said Aurobindo sent a letter back in April informing them that the company had submitted an abbreviated new drug application (ANDA) for a generic version of Erleada. According to the defendants — Aurobindo and its units Eugia Pharma and AuroMedics — the generic doesn’t infringe on J&J’s patents because it doesn’t contain crystalline Form B of apalutamide, the active ingredient in Erleada.
The plaintiffs claimed that they requested more information regarding the ANDA, but the defendants didn’t respond.
“By failing to provide information, Defendants impeded Plaintiffs’ ability to evaluate infringement of the 663 Patent,” the complaint states.
However, on information and belief, the plaintiffs alleged that Aurobindo’s generic contains some amount of crystalline Form B of apalutamide.
The plaintiffs are looking for a ruling that Aurobindo has infringed on Erleada’s patents through its ANDA submission and that the manufacturing or commercialization of a generic would also infringe upon those patents.
Neither J&J nor Aurbindo responded to a request for comment.
Erleada was first approved for non-metastatic castration-resistant prostate cancer back in 2018, months ahead of its PDUFA date. At the time, Evaluate Pharma pegged 2022 sales at $1.6 billion, which is possible considering the drug raked in nearly $1.3 billion last year, up from $760 million the year before. J&J lined Erleada up as a successor to the bestselling Zytiga as generic competition closes in.
In 2019, J&J expanded Erleada’s label to include patients with metastatic castration-sensitive prostate cancer.