Par Pharmaceutical Companies, Inc announced that the US District Court for the District of Delaware has ruled in favour of Par in its challenge of the University of Missouri's patents relating to omeprazole/sodium bicarbonate capsules (20 mg/1.1 g and 40 mg/1.1 g) and powders for oral suspension (20 mg/1.68 g and 40 mg/1.68 g), which are listed in the Orange Book for Santarus's Zegerid product. Par earlier announced that it had filed an ANDA seeking marketing approval for generic omeprazole/sodium bicarbonate capsules and powders for oral suspension, and that it was the first-filed ANDA with respect to the Zegerid product.
Par currently has tentative approval on both strengths of the Zegerid capsule product. Par intends to review its options with respect to its omeprazole/sodium bicarbonate ANDA.
Par Pharmaceutical Companies is a US-based specialty pharmaceutical company. Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals.