FDA approval for OTC delayed release omeprazole in US

Over-the-counter (OTC) drug manufacturer and marketer Perrigo has said that the FDA has granted final approval to its partner Dexcel Pharma Technologies to sell 20 mg omeprazole delayed-release tablets in the US.

As the exclusive marketer and distributor of this product for the store brand OTC market in the US, Perrigo expects to begin shipping its product during Q1 2008. The company says its full year annual sales could be in the region of USD 150m to USD 200m.

Omeprazole is the active ingredient in UK-headquartered AstraZeneca's now off-patent antacid blockbuster Prilosec. Prilosec OTC is indicated for the treatment of frequent heartburn and had estimated current annual sales of approximately USD 750m in all US outlets, says Perrigo.

Based on pre-launch estimates, Perrigo's Omeprazole product is expected to contribute between USD 0.20 and USD 0.25 earnings per share in FY08. As a result of the Omeprazole launch, FY08 earnings are expected to be in the range of USD 1.32 to USD 1.47 per share.

Omeprazole is also sold OTC in a non-delayed release form by Proctor & Gamble.