Novartis Sues FDA to Reverse Generic Entresto OK
Novartis has filed a lawsuit against FDA that seeks to reverse the agency’s recent approval of MSN Laboratories’ generic version of Novartis’s Entresto (sacubitril/valsartan), indicated for reducing the risk of cardiovascular death and hospitalization in adult patients with chronic heart failure.
Novartis argues that FDA’s conduct in approving the generic product and denying two citizen petitions submitted by Novartis is unlawful. “FDA has asserted that it may approve generic labeling that inappropriately rewrites Entresto’s approved indication and reverts to a superseded indication in an effort to avoid Novartis’s patents,” it says. By doing this, Novartis says the agency violated its implementing regulations, which provide that generic labeling may omit an indication that is subject to patent rights, but not add wording or make other changes to an indication remaining in the labeling.
The lawsuit also contends that MSN’s generic product “unlawfully deletes critical safety information contained in the Entresto labeling. Under the agency’s own regulations, FDA may not delete study information or other instructions from the labeling of a generic drug product in order to avoid patent infringement if doing so would impact the safety or effectiveness of the resulting product.”
Additionally, the lawsuit challenges an FDA response (see earlier story) to a citizen petition in which the agency “bound itself to approve generics that do not have identical active ingredients to Entresto, as would be required to support approval of a generic drug.” Novartis says Entresto has two active ingredients, sacubitril and valsartan, “which exist in a specific and well-defined salt form, or chemical structure, in the finished drug product. FDA has taken the position that generic drug products do not need to have this same chemical structure, and instead may contain forms of Entresto’s active ingredients that are not present in Entresto itself. That is unlawful.”
Novartis’s lawsuit also seeks a temporary restraining order to block the generic launch. “Time is of the essence in this case,” it says. “MSN’s approval permits MSN to flood the market at any moment, creating imminent and irreparable harm to Novartis.”