Ranbaxy exploited the FDA’s “abbreviated new drug applications” (ANDAs) in order to secure valuable first-to-file generic status and lucrative 180-day exclusivity that comes with the first-to-file status.
In re Ranbaxy Generic Drug Application Antitrust Litigation
SOURCE: In re Ranbaxy Generic Drug Application Antitrust Litigation | Cohen Milstein
On April 28, 2022, Judge Nathanial M. Gorton of the United States District Court for the District of Massachusetts granted preliminary approval of a $485 million global settlement to resolve claims against Ranbaxy in this antitrust, federal RICO, and state consumer protection MDL for allegedly manipulating the U.S. Food and Drug Administration’s generic drug approval process to block competitors from coming to market and forcing purchasers to pay supracompetitive prices for its valganciclovir hydrochloride and valsartan products. Of the $485 global settlement, pending final approval, $340 million will go to the certified class of Direct Purchasers.
Prior to the global settlement, on May 14, 2021, the court granted class certification to both Direct Purchaser and End-Payor Plaintiffs.
Cohen Milstein represents the Direct Purchaser Class.
Case Background
Originally filed by Direct Purchaser Plaintiffs in May 2015 in federal court in Massachusetts and subsequently consolidated with a lawsuit filed by End-Payor Plaintiffs, Plaintiffs allege that starting in the early 2000’s, Ranbaxy exploited the FDA’s “abbreviated new drug applications” (ANDAs) in order to secure valuable first-to-file generic status and lucrative 180-day exclusivity that comes with the first-to-file status. (During this exclusivity period no other manufacturer is permitted to market a generic version of the subject drug.) Among other things, Plaintiffs claim that Ranbaxy filed numerous ANDAs, many of them filled with misleading or false representations, including that Ranbaxy facilities and procedures were (or would soon to be) in compliance with manufacturing requirements for the production of the products. In so doing, as each of the ANDAs came up for review, Ranbaxy dragged out the review processes with the FDA, further delaying any would-be generic manufacturer seeking to enter that particular drug market.
Specifically, Plaintiffs claim, in 2004 and 2005, Ranbaxy submitted the first substantially complete ANDAs for three brand drugs at issue: Diovan, Nexium and Valcyte. It subsequently obtained tentative approval from the FDA for its ANDAs for each of those drugs in 2007 and 2008. Despite its early success, Ranbaxy failed to secure final approval for its generic version of Diovan until June 2014 and did not bring that generic to market until July 2014.
During this time, Plaintiffs further claim, the FDA obtained a consent decree in 2012 to address Ranbaxy’s regulatory compliance issues, and in 2013, the U.S. Department of Justice imposed a $500 million criminal fine and civil penalty on Ranbaxy for past transgressions. Having uncovered Ranbaxy’s scheme and before Defendant could secure final approval for its generic Nexium and Valcyte ANDAs, the FDA revoked its tentative approval for both drugs in 2014 and Ranbaxy’s generic versions were never brought to market.
Plaintiffs assert that but for defendants’ allegedly anti-competitive conduct, generic versions of those three drugs would have entered the market and been available at lower prices much sooner. As a result, Plaintiffs contend they paid artificially inflated prices for generic versions of Diovan, Nexium and Valcyte during the Class Periods.
This case is styled: In re Ranbaxy Generic Drug Application Antitrust Litigation, Case N. 1:19-md-02878-NMG (MDL No. 2878), U.S. District Court, District of Massachusetts
The original Direct Purchaser case was styled: Meijer, Inc. et al. v. Ranbaxy Inc., et al., Case No. 1:15-cv-11828-NMG, U.S. District Court, District of Massachusetts
