Last week, the FDA rejected Vanda Pharmaceutical’s Citizen Petition requesting that FDA withhold approval of ANDAs for its schizophrenia drug, Fanapt®, for three years.  (Letter from Janet Woodcock, M.D., Director Center for Drug Evaluation and Research, to Richard L. Gulino, Senior Vice President, General Counsel and Secretary, Vanda Pharmaceuticals Inc., dated Nov. 28, 2016.)  Specifically, the FDA rejected Vanda’s efforts to force generic products to include labeling statements that were the source of Fanapt®’s three-year grant of exclusivity.

Fanapt® was first approved in 2009 with a label stating that “[t]he effectiveness of FANAPT in long-term use, that is, for more than 6 weeks, ha[d] not been systematically evaluated in controlled trials” (“Acute Dose Statement”).  Thereafter, in May 2016, the FDA approved Vanda’s efficacy supplement (sNDA) demonstrating that patients with schizophrenia who continued taking Fanapt® for 12 weeks after an initial psychotic event showed a delay in time to relapse compared to placebo.  This enabled Vanda to remove the Acute Dose Statement in favor of language explaining that “[i]n a longer-term study, FANAPT was effective in delaying time to relapse in patients with schizophrenia who were stabilized on FANAPT” (“Maintenance Dose Statement”).  Fanapt® received three years of Hatch-Waxman exclusivity for conducting the clinical trial (“Reprieve”) underlying the Maintenance Dose Statement.

Vanda argued that the three-year grant of exclusivity (1) protected both the addition of the Maintenance Dose Statement and the deletion of the Acute Dose Statement and (2) precluded approval of any ANDA that did not include the Maintenance Dose Statement.  The FDA rejected both arguments.

In rejecting the former, the FDA explained that “[e]xclusivity provides the holder of an approved new drug application limited protection from new competition in the marketplace for the innovation represented by its approved drug product.”  54 Fed. Reg. 28896-97 (emphasis added).  The FDA interpreted this to mean that exclusivity does not extend beyond the scope of the approval of the application or supplement.  Here, the FDA concluded that the Maintenance Dose Statement was the only exclusivity-protected change.  In other words, although the FDA permitted additional changes to the label (i.e., removal of the Acute Dose Statement), that did not mean those conforming changes were included in the scope of exclusivity.  Accordingly, labels omitting the exclusivity-protected Maintenance Dose Statement do not violate Fanapt®’s exclusivity.

The FDA also rejected Vanda’s argument that all competing labels must include the Maintenance Dose Statement on the basis of safety and efficacy.  The FDA’s approval of Fanapt®’s NDA was not contingent on conducting the Reprieve study, and therefore it was not essential for the safe and effective treatment of schizophrenia.  Thus, ANDA-filers are free to “carve out” the Maintenance Dose Statement.

The FDA’s decision paves the way for generic challenges to Fanapt®, which claims patent protection until 2031.  The decision also demonstrates an instance where an RLD obtained a grant of market exclusivity from the FDA, but is nevertheless susceptible to generic competition.