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Capabilities

Generic Drug Withstands Litigation and Regulatory Threats

 
Case Study

Situation

A generic pharmaceuticals company faced a major business disruption after a competitor filed a new drug application for potassium chloride. The Food and Drug Administration (FDA) approved the application and asked our client to cease sales of its legacy product.

Result 

Husch Blackwell litigators defended proceedings brought by the competitor and simultaneously sued the FDA in federal court over the agency’s generic drug policy. We also worked with U.S. customs to ensure that our client’s supply of potassium chloride was not interrupted during the pendency of an ITC proceeding. Thanks to Husch Blackwell’s vigorous defense, a confidential agreement was reached with the owner of the FDA-approved product that allowed our client to continue providing its generic version.