News > RMMS Secures Summary Judgment Against Otsuka Related To Generic Aripiprazole (Abilify®)

RMMS Secures Summary Judgment Against Otsuka Related To Generic Aripiprazole (Abilify®)

05/27/2015

Nearly a month after RMMS successfully defeated Otsuka's motion for temporary restraining order, RMMS secured a second victory in the U.S. District Court for the District of Maryland, on behalf of its client Apotex Inc. The Court granted FDA and Intervenor Defendant's summary judgment ("SJ") motions and denied Otsuka's cross SJ motion which could have blocked final approval of generic aripiprazole products until December 2021—when orphan drug exclusivity expires for Abilify®’s Tourette’s disorder indication. 

In a 28-page opinion, U.S. District Judge George J. Hazel held that Otsuka failed to cite to any evidence in support of its construction of a statutory provision relating to pediatric labeling information—specifically noting that “it would defy logic to believe that in enacting [a] measure to prevent three-year exclusivity from becoming a 'fundamental abuse of the system' that harmed consumers, Congress nontheless intended to permit the [abuse of the] seven-year exclusivity Otsuka seeks here. The Court concludes that it did not.” Judge Hazel concluded that FDA’s decision to approve generic aripiprazole applicants “reasonable” in light of the plain language of the Orphan Drug Act, Fourth Circuit case law interpreting the same, and FDA’s own regulations.  

The RMMS team included William RakoczyLara FitzSimmonsTrang Hoang, and Chris Galligan.