ViroPharma Inc. sued two federal agencies seeking a court order temporarily blocking approval of generic forms of its biggest product, the antibiotic Vancocin.
Arguing that the U.S. Food and Drug Administration’s approval of three companies’ generic formulations was arbitrary and capricious, Exton, Pennsylvania-based ViroPharma also asked for a court order reversing that agency’s decision and granting it a three-year window of exclusivity.
In its complaint filed today in federal court in Washington, ViroPharma described Vancocin as a “drug of last resort,” against life-threatening gastrointestinal infections, from which it derives about half its revenue.
“The entry of these three generic products into the market is expected to cause ViroPharma irreparable harm in the form of significant and swift lost sales of Vancocin,” according to the company’s complaint. Those sales were about $289 million last year.
ViroPharma fell 22 percent to $22.44 at the close of New York trading on April 10 after announcements by two companies, Akorn Inc. and Watson Pharmaceuticals Inc., that the FDA had approved their copies of the drug. ViroPharma fell 7 cents to $22.01 today in Nasdaq trading.
The FDA’s Office of Public Affairs didn’t immediately reply to a voice-mail message after regular business hours seeking comment on the lawsuit. Also named as a defendant is the federal Department of Health and Human Services, under whose authority the FDA operates.
Akorn and Watson aren’t direct parties to the litigation.
The case is ViroPharma Inc. v. Hamburg, 12-cv-584, U.S. District Court for the District of Columbia (Washington).