Genus Lifesciences Contests FDA’s Approval of Cocaine Hydrochloride Drug

Genus Lifesciences filed suit against the FDA in the U.S. District Court for the District of Columbia, alleging that the agency violated the 5-year exclusivity of a Genus product in approving a competitor’s application for a rival product.

The FDA approved the Allentown, Pennsylvania drugmaker’s Goprelto (cocaine hydrochloride), a nasal spray indicated for inducing local anesthesia, in December 2017, granting a 5-year new chemical entity exclusivity.

Genus argued that the exclusivity blocks the submission of rival drug applications for agency review if they include the same active ingredient. The complaint alleges that the FDA allowed a generic competitor, Lannett, to submit an application for its cocaine hydrochloride product, Numbrino, and failed to hold it to the same acceptance standards.