Lupin 2023

Novartis agrees $245m settlement over Exforge generics delay

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NEW YORK — Novartis announced  this week that it will pay $245 million to resolve civil litigation in the US which accuses it of a ‘pay for delay’ scheme involving generics of its high blood pressure therapy Exforge.

The case is about allegations that Novartis made an agreement in 2011 with Par Pharmaceutical when Exforge (valsartan/amlodipine) was nearing the end of its patent life that was designed to keep Par’s generic version of the drug off the market until 30 September, 2014.

The complaint claims that Par agreed not to launch its generic, in return for Novartis not launching a patent infringement suit and agreeing not to launch its own authorised generic of the drug until 30 March, 2015, giving Par a valuable six months to sell its generic unopposed in the market. The FDA granted full approval to Par’s generic March 28, 2013.

Plaintiffs – in this case direct purchasers, indirect purchasers and retailers including CVS Health, Kroger, Rite Aid and Walgreens Boots Alliance according to Reuters – filed suit against Novartis and Par in 2018 alleging violation of federal antitrust laws.



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