Ranbaxy Generic Drug Application Antitrust Litigation

KTMC was counsel for direct purchasers alleging that generic drug manufacturer, Ranbaxy, Inc., violated the racketeering laws by recklessly submitting grossly inadequate generic drug applications to the FDA for generic versions of Nexium, Diovan and Valcyte; and intentionally deceiving the FDA into granting tentative approval to secure statutory exclusivities for each application.  These improperly obtained approvals gave Ranbaxy the power to exclude other generic manufacturers’ versions of these drugs while its own applications floundered. Had Ranbaxy not made blatant misrepresentations to the FDA, the FDA would not have granted Ranbaxy the tentative approvals and resulting exclusivities, and other companies would have entered the market with generic versions of each drug several years earlier.  As a result of Ranbaxy’s unlawful conduct, purchasers paid significantly higher prices for these drugs than they otherwise would have.

After several years of hard-fought litigation, Judge Nathaniel M. Gorton certified three separate classes of direct purchasers of each drug and denied Ranbaxy’s motion for summary judgment.  On the eve of trial, Plaintiffs negotiated a $340 million settlement on behalf of the three classes of direct purchasers.