Last week, we reported on K-V Pharmaceutical’s (“KV”) litigation against the FDA seeking to require the agency to enforce KV’s exclusive rights to market its brand drug, Makena®. As we noted, KV asserted in the case that it would likely run out of cash if the court did not grant the injunctive relief KV sought. On August 4, 2012, KV and certain KV subsidiaries filed voluntary petitions under Chapter 11 of the United States Bankruptcy Code. In its press release KV states:
[KV] has been unable to realize the full value of its most important product, Makena® . . . because of a lack of enforcement of the orphan drug marketing exclusivity granted to K-V for Makena® by [FDA] . The lack of enforcement has also led certain state Medicaid agencies to impose barriers to access to Makena® on low-income pregnant women at high risk for recurrent preterm birth, despite those states’ legal obligation to cover FDA-approved drugs.
At this point, it is unknown how the bankruptcy will impact KV’s ability to continue to fund the Makena® litigation.
