Perrigo Receives FDA Approval for Generic Nexium 24HR

Key Insights

• Perrigo has secured FDA approval for its over-the-counter store brand equivalent of Nexium 24HR (esomeprazole magnesium capsules).
• A patent litigation settlement with AstraZeneca allows Perrigo to launch its generic esomeprazole product in late September 2017.
• The generic medication offers consumers a cost-effective alternative for treating frequent heartburn, occurring two or more days a week.

Perrigo Company plc (PRGO) announced FDA approval for its store brand, over-the-counter (OTC) equivalent of Nexium 24HR (esomeprazole magnesium capsules), offering a more affordable option for consumers suffering from frequent heartburn. The approval paves the way for the launch of the generic medication in late September 2017, following a patent litigation settlement with AstraZeneca.

Settlement with AstraZeneca

The settlement resolves a patent dispute, enabling Perrigo to introduce its version of esomeprazole magnesium capsules to the market. This agreement is crucial for ensuring that consumers have access to a lower-cost alternative to the branded medication. The product will be marketed under store brand or retailer 'own label' branding.

Clinical Indication and Market Opportunity

Nexium 24HR (esomeprazole magnesium) capsules are indicated for the treatment of frequent heartburn, defined as heartburn occurring two or more days per week. The market for this medication is substantial, with annual retail sales for Nexium 24HR exceeding $300 million. Perrigo's generic version aims to capture a significant portion of this market by providing a high-quality, value alternative to the branded product.