ALLEGAN — Perrigo Co. (Nasdaq: PRGO) and its partner Synthon Pharmaceuticals, Inc. today announced that Perrigo has begun shipping Levocetirizine Solution, 2.5 mg/5ml, a generic version of UCB’s Xyzal Oral Solution.
Synthon has the first to file ANDA application for the generic that entitle it to 180 days of generic exclusivity. Hatch Waxman litigation in this product was settled earlier this year. Perrigo is the manufacturer of this product.
Xyzal Oral Solution is indicated for the treatment of indoor and outdoor allergies. It is estimated that it has annual sales of approximately $12 million, according to data provided by Wolters, Kluwer.
Perrigo’s Chairman and CEO Joseph C. Papa concluded, “This is another example of Perrigo’s commitment to bring new products to market. Perrigo continues to deliver on its mission to provide quality, affordable healthcare to consumers.”
Synthon’s CEO Rudy Mareel commented, “Levocetirizine is a prime example of several ANDAs for which Synthon has obtained ‘First-Filer’-status with 180 days Hatch-Waxman marketing exclusivity. The successful launch of Levocetirizine oral solution yet again is proof to Synthon’s achievements and our fruitful cooperation with Perrigo.”
Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients. The company 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.