Eisai said it and Glenmark reached a settlement of the Japan drugmaker's U.S. suit for patent infringement of its Banzel (rufinamide) epilepsy drug.
In a release, Eisai said the India generics maker would be allowed to market its Banzel version as early as May 30, 2022, or sooner under certain circumstances it did not identify.
Other than that, Eisai offered no more information about the settlement, which it said was confidential. The drug was first approved by the U.S. FDA in 2008, and is set to lose its orphan-drug exclusivity in November and pediatric exclusivity a year after that.
Eisai begins to lose patent protection in late 2018 and mid-2019, except for its pediatric patent expiring in 2023; its remaining patent expires in 2022 when Glenmark begins marketing.
- here's the release