ALLEGAN — Perrigo Co. (Nasdaq: PRGO) announced that the United States Food and Drug Administration has granted final approval to Tris Pharma for its abbreviated new drug application for Dextromethorphan Polistirex Extended-Release Oral Suspension, the store brand equivalent to Reckitt Benckiser’s Delsym suspension.
As the exclusive marketer and distributor of this product for the store brand over-the-counter market in the United States, Perrigo expects to begin shipping its product during its first fiscal quarter of 2013.
Litigation between Tris and Reckitt Benckiser is ongoing in the United States District Court for the District of New Jersey, where the court has previously granted summary judgment of non-infringement of the asserted patent claims. As the Tris ANDA was the first one submitted with a paragraph IV certification, marketing of the product is entitled to 180 days of generic exclusivity.
Delsym is indicated for the treatment of cough due to minor throat and bronchial irritation. Perrigo estimates the past year’s sales for the brand were approximately $110 million.
“This approval further highlights our ability to bring new products to our consumers and reinforces our continued focus of making quality healthcare more affordable,” Perrigo chairman and CEO Joseph C. Papa said. “We are pleased to add this important new product to our retail and wholesale customers’ store brand product portfolios when we begin shipments to them for the upcoming cough/cold/flu season.”
Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients. Perrigo is the world’s largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.
More at www.perrigo.com.