Novartis pays $245M to settle Exforge generic pay-for-delay lawsuit

Novartis has decided to end a classic generic pay-for-delay legal battle with a series of settlements.

The Swiss pharma will pay altogether $245 million in separate settlements with direct purchasers, indirect purchases and retailers who had accused the company of colluding with Endo’s Par Pharmaceutical to push back the launch of a generic version of Novartis’ high blood pressure med Exforge. A Novartis spokesperson confirmed the agreement with Fierce Pharma.

Once approved by a federal judge in New York, the settlements will “resolve all outstanding claims” related to the Exforge case, Novartis said in a statement. Of the settlements with the three plaintiff groups, the one made with the retailer class—including pharmacies like CVS and Walgreens—doesn’t require court approval and will remain confidential, the spokesperson explained.

The litigation started in 2018 and centered on an agreement Novartis and Par signed in 2011. As part of the deal, Par agreed not to launch a generic version of Exforge until September 2014, more than two years after the expiration of a patent, according to a complaint. In exchange, Novartis agreed not to launch an authorized generic of Exforge during a 180-day period of exclusivity that the FDA granted to the Par version as the first copycat of the Novartis drug.

Without that deal, Par would have launched its generic as early as September 2012, when the patent expired, or March 2013 at the latest, when the generic got its final FDA approval, the plaintiffs argued.

The lawsuit alleged that as a result of the agreement between Novartis and Par, the plaintiffs paid more for brand and generic Exforge than they otherwise would have. The so-called “pay for delay” agreement violated federal antitrust laws, the plaintiffs said. Novartis denied those allegations and didn’t admit to any wrongdoing in a public settlement agreement with the direct purchasers.

Lawsuits challenging the legality of pay-for-delay deals are common in the biopharma industry. Such deals typically involve a branded drugmaker compensating a generic competitor to delay the launch of a generic product. In 2022, AbbVie inked a $54 million deal to settle pay-for-delay claims around its Alzheimer’s disease drug Namenda. AstraZeneca is battling a similar claim targeting its antipsychotic Seroquel XR. Par was also one of the defendants in another reverse payment lawsuit over Takeda’s constipation drug Amitiza. 

Ending the Exforge civil case marks another step for Novartis to put some of its legacy problems behind it. The settlements allow Novartis to focus on its current business, the company said in a statement.

Back in 2020, the Swiss pharma agreed to a $729 million settlement to end litigation alleging that it used sham speaker programs and events to offer kickbacks to doctors to boost prescription of its drugs, including Exforge.

Also in 2020, Novartis shelled out $347 million and admitted to bribing doctors in several countries under the U.S. Foreign Corrupt Practices Act. It also paid $195 million as part of an industrywide generics price-fixing scheme that also implicated several companies such as Teva, Mylan and several Indian generic drugmakers.