Novartis to Pay $245 Million in ’Pay for Delay’ Settlement
Novartis has agreed to pay a total of $245 million to settle lawsuits filed by direct purchasers, indirect purchasers and retailers accusing it of colluding with Par Pharmaceutical to delay the launch of a generic version of its Exforge (valsartan/amlodipine) hypertension drug.
If approved by a federal judge in the US state of New York, the settlement will “resolve all outstanding claims” from the three groups of plaintiffs in the Exforge case, the Swiss drugmaker said. According to reports, the out-of-court settlements with US drug retailers such as pharmacy chains CVS and Walgreens don’t require approval and terms won’t be disclosed.
The lawsuits filed in 2018 center on what the plaintiffs asserted was a “classic pay to delay deal” sealed by Novartis and Par in 2011 in which the Endo subsidiary agreed not to launch a generic version of Exforge until September 2014, more than two years after the Novartis patent was due to expire.
In exchange, the Basel-based pharma pledged that its subsidiary Sandoz would not launch a generic version of Exforge during the 180-day period of exclusivity the FDA would grant the Par version as the first producer of a generic.
The plaintiffs argued that due to the delay of a generic copy they paid more than they should have for both the branded drug and its delayed copy. Moreover, the agreement violated federal antitrust laws. Novartis denied the allegations and under the terms of the settlement with the direct purchasers did not admit any wrongdoing.
Novartis said ending the lawsuits will allow it to focus on its current business. According to court documents cited by the Reuters news agency, annual sales of Exforge in the US topped $400 million before generic versions hit the market.
Author: Dede Williams, Freelance Journalist
