Biovail Sues Maker of Generic Version of Wellbutrin XL, FDA Files Opposition

According to Therapeautics Daily, Ontario-based pharmaceutical company Biovail has sued Impax Laboratories, the maker of the newly approved generic version of Wellbutrin XL, claiming patent infringement. They are seeking a court order that will suspend the U.S. Food and Drug Administration approval and stop Impax from distributing the drug.

The FDA has filed a formal opposition to their move, claiming that Biovail did not meet the 45-day deadline for filing their lawsuit on 300 mg Wellbutrin XL. They did, however, meet the deadline on the 150 mg dosage.

In its filing, the FDA said, "Biovail has failed to establish either irreparable harm or that it is likely to succeed on the merits."

No comment was made by Biovail.