HYDERABAD, India — Aurobindo Pharma Ltd. has received Food and Drug Administration approval to manufacture over-the-counter 20-mg esomeprazole magnesium delayed-release capsules, an antacid.
Aurobindo said its esomeprazole OTC product, being shipped immediately, is a generic version of Nexium 24HR capsules from Pfizer Consumer Healthcare.
A proton pump inhibitor (PPI), Nexium 24HR capsules are indicated for the treatment of frequent heartburn, defined as heartburn occurring two or more days a week. The medication works by stopping acid production at the source via blockage of the pumps that release acid into the stomach. PPIs like Nexium 24HR are the only FDA-approved medications for the nonprescription treatment of frequent heartburn.
Annual U.S. sales of Nexium 24HR are more than $300 million, according to IRI data reported by Aurobindo.
Pfizer rolled out Nexium 24HR in the spring of 2014 shortly after receiving FDA approval, in which the company was granted three-year market exclusivity for the product. Pfizer had acquired global OTC rights to Nexium from AstraZeneca in August 2012. Nexium 24HR, however, could be going on the block after Pfizer announced earlier this month that it was exploring strategic alternatives for its Consumer Health unit, including a potential sale of the business.