Perrigo receives FDA approval for store brand equivalent to Nexium 24HR
Dublin, Ireland-based Perrigo Co. said last week that it has received final approval from the U.S. Food & Drug Administration for the store brand over-the-counter equivalent to Nexium 24HR (esomeprazole magnesium) capsules. The company also disclosed that it has reached a settlement of patent litigation with AstraZeneca allowing for the Nexium 24HR-equivalent capsules to launch in late September.
The Perrigo product will be packaged and marketed as a private brand and will provide consumers with a high-quality, value alternative to Nexium 24HR capsules, the company said.
Nexium 24HR capsules are indicated for frequent heartburn (occurring two or more days a week). Approximate annual retail sales for the past 12 months were in excess of $300 million.
"This final approval and upcoming launch demonstrates the tremendous capabilities of our leading store brand OTC platform,” said Jeff Needham, Perrigo’s executive vice president and president of its Consumer Healthcare Americas division, in a statement.