On November 22, 2021, the U.S. District Court for the District of Massachusetts denied summary judgment motions in antitrust and RICO class action lawsuits alleging that Ranbaxy manipulated the FDA generic drug approval process to prevent competitors from developing generic versions of three drugs: the anti-AIDS drug Valcyte (valganciclovir), the high blood pressure medication Diovan (valsartan), and the acid reflux medication Nexium (esomeprazole). The Court rejected defendants’ motion despite the fact that Ranbaxy never sold two of the three generic drugs at issue, and thus never maintained a share of the relevant markets. The Court found that, while an antitrust defendants’ share of the relevant market is typically used as evidence of monopoly power, this is not necessary in the highly-regulated market for pharmaceuticals. The allegations provided sufficient evidence to create a genuine dispute of material fact as to whether Ranbaxy maintained monopoly power due to its first-filer status and the resulting exclusionary periods. This would give Ranbaxy the ability to reduce or destroy competition in the relevant market. The trial is currently scheduled for January 10, 2022.

On May 14, 2021, the court certified two purchaser classes, a direct purchaser class and an end payor class, against Ranbaxy. In the mid-2000s, Ranbaxy filed abbreviated new drug applications for generic versions of the three drugs at issue. The class plaintiffs allege that the applications contained missing, incorrect, or fraudulent information and were submitted despite these defects to obtain valuable exclusivity periods that would block other manufacturers from offering generic versions of these drugs. Ranbaxy only brought its generic version of Diovan to the market in July 2014 and never obtained final approval to bring its generic versions of Valcyte and Nexium to the market.

In re: Ranbaxy Generic Drug Application Antitrust Litigation, MDL No. 19-md-02878 (D. Mass.)