The new formulation is an immediate-release tablet that combines omeprazole, a proton pump inhibitor, with a mix of buffers.
The new drug application (NDA) was submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. If the NDA is accepted for filing by the FDA, Santarus will provide notice to the NDA holder for Prilosec and related patent holders that the new tablet formulation does not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.
Zegerid (omeprazole/sodium bicarbonate) capsules and powder for oral suspension are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease, maintenance of healing and short-term treatment of erosive esophagitis, and short-term treatment of active benign gastric ulcers and active duodenal ulcers.
The company’s objective is to have the new Zegerid tablet product commercially available in the US in the fourth quarter of 2009.