Par Pharmaceuticals Settles With Salix Over Generic ZegeridBy
Par Pharmaceuticals Companies Inc. reported that it had reached a $100-million settlement with the specialty pharmaceutical company Salix Pharmaceuticals, Inc. Santarus, Inc. (a specialty pharmaceutical acquired by Salix in January 2014), and the University to resolve all claims relating to Par’s sales, beginning in July 2010, of its 20-mg and 40-mg generic version of Zegerid (omeprazole/sodium bicarbonate) capsules.
In 2007, Santarus and the University of Missouri filed a lawsuit against the Part in federal district court for patent infringement regarding the company’s abbreviated new drug application for 20-mg and 40-mg omeprazole/sodium bicarbonate capsules. Later in 2007, Santarus and Missouri filed a second lawsuit alleging infringement of the patents over the 20-mg and 40-mg omeprazole/sodium bicarbonate powders for oral suspension. In April 2010, the federal district court ruled in favor of Par, and the company launched its 20 mg and 40 mg generic omeprazole/sodium bicarbonate capsules product. Santarus and Missouri appealed the district sourt's decision to the US Court of Appeals for the Federal Circuit, and Par cross-appealed the district court's decision of enforceability of plaintiffs' patents. On September 4, 2012, the Court of Appeals reversed the district court's finding of invalidity and remanded to the district court for further proceedings, and Par ceased further distribution of its 20-mg and 40-mg generic omeprazole/sodium bicarbonate capsules product. Santarus was acquired by Salix on January 2, 2014.
In settling, Par has agreed to refrain from the reintroduction of its generic Zegerid products until the expiration of plaintiffs' patents, the unextended terms of which end July 16, 2016.