DC Court Rules for FDA on Marketing Exclusivity

The DC federal court has ruled in FDA’s favor in a lawsuit brought by Otsuka that sought to reverse the agency’s approval of Alkermes’ 505(b)(2) NDA for Aristada (aripiprazole lauroxil) extended-release injectable suspension. The 2015 agency Aristada approval came after it denied an Otsuka petition asking that it delay approval at least until the expiration of Otsuka’s three-year exclusivity for its Abilify (aripiprazole) and not approve the Alkermes NDA in its entirety because it did not satisfy the regulatory substantial evidence of effectiveness requirement since it was supported by only one clinical trial. In its denial letter, FDA said it disagreed with Otsuka’s analysis since the NDAs are for different active ingredients and since Aristada has a new chemical entity and thus its own five-year period of exclusivity.

The Otsuka suit said that aripiprazole lauroxil “is not, by any means or by any definition, an innovative drug. It does not, for example, represent a therapeutic advance, nor does it provide any new or additional therapeutic benefit beyond that provided by Otsuka’s Abilify Maintena.” It said that FDA has referred to aripirprazole as an active metabolite in aripiprazole lauroxil and that Alkermes has said that the active moiety of aripiprazole lauroxil is aripirprazole.

“Despite the fact that both Abilify Maintena and Aristada are long-acting injectable formulations of aripiprazole indicated for the same conditions of use, FDA, in denying Otsuka’s citizen petition, determined that Abilify Maintena and Aristada have different active moieties and, therefore, Aristada is not blocked by Otsuka’s exclusivity covering aripiprazole,” the suit said. “FDA then reversed field and simultaneously determined that the Aristada NDA could rely upon Otsuka-developed safety and efficacy data for aripiprazole to meet the FDCA’s drug approval requirements for Aristada. So, in a regulatory sleight of hand, FDA determined that Abilify Maintena and Aristada are different for purposes of exclusivity, but because aripiprazole is the only active therapeutic agent in both (i.e., the same), that Aristada could rely upon Otsuka’s aripiprazole safety and effectiveness data.”

In the 7/28 ruling, the court “concludes that the FDCA’s terms do not unambiguously preclude the FDA from viewing the exclusivity bar as pertaining only to drugs that contain the same active moiety as the drug with exclusivity, and, in fact, the court finds that the FDA’s interpretation of the FDCA’s exclusivity provisions is entirely reasonable. Furthermore, to the extent that the FDA reads its own implementing regulations in the same way as it has interpreted the pertinent statutory provisions, this court concludes that the agency’s reading is not plainly erroneous and is entitled to deference. In this same vein, the court also finds that the agency’s resolution of the regulation’s ambiguity through its active-moiety interpretation is not a ‘de facto’ rulemaking, as Otsuka argues. Consequently, the summary judgment motions that the FDA and Alkermes have submitted must be granted; Otsuka’s motion for summary judgment must be denied; and Otsuka’s claims against the FDA will be dismissed.”