Biovail Corporation (Canada) filed suit yesterday in the U.S. District Court for the District of Columbia against the U.S. Food and Drug Administration. Biovail's complaint and motion for a temporary restraining order and preliminary injunction request the court to compel FDA action on Biovail's citizen petition submitted in December 2005 relating to the criteria used in evaluating generic applications for Wellbutrin XL. Biovail further requested that the court order the FDA to rule on its citizen petition at least one week prior to any FDA approval of generic Wellbutrin XL.
Wellbutrin XL is an extended release version of the popular Wellbutrin (bupropion hydrochloride) antidepressant that is manufactured by Biovail Corporation for GlaxoSmithKline. GSK faces suit for alleged antitrust violations related to Wellbutrin SR, a different sustained release version of bupropion hydrochloride, as previously reported in Orange Book Blog.
Biovail's complaint alleges that the FDA has failed to rule on generic bioequivalence issues raised in its citizen petition within the required 180 day period, and that those issues are of critical importance given bupropion's association with dose-related risk of seizures that can be life-threatening. Biovail further alleges that FDA routinely refuses to decide citizen petitions within the required 180 days when the petitions relate to specific criteria for reviewing proposed generic versions of prescription drugs, and instead withholds its decisions on such petitions until after it approves the generic version. Biovail argues that this FDA practice deprives the courts of the opportunity to timely review FDA decisions on citizen petitions, potentially leading to consumer exposure to unsafe generic drugs.
In a related action, Biovail filed suit in December 2004 in the U.S. District Court for the Central District of California against Anchen Pharmaceuticals (Irvine, CA), the first Paragraph IV generic filer for Wellbutrin XL. The district court in that case ruled in favor of Anchen on summary judgment on August 2, 2006, holding that Anchen did not infringe Biovail's patents. Since Anchen received tentative FDA approval for generic Wellbutrin XL on November 14, 2005, Biovail and GSK are concerned that Anchen may soon launch a generic version of Wellbutrin XL.
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