Perrigo Company (Nasdaq: PRGO; TASE) announced on May 26, 2010 that it had acquired rights to Novel Laboratories' pending ANDA for HalfLytely® and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablets). On May 27, 2010, Novel received tentative approval from the U.S. Food and Drug Administration on its ANDA for the generic version of HalfLytely®. Annual sales for the Braintree Laboratories brand were approximately $80 million according to Wolters Kluwer.
Novel is believed to be first to file and Perrigo expects to be in a position to launch a generic version to HalfLytely® and Bisacodyl Tablets Bowel Prep Kit at the expiration on the brand exclusivity, on or about September 25, with 180 days of generic exclusivity. The company has not been sued. Under terms of the Perrigo/Novel agreement, Novel will manufacture the product exclusively for Perrigo.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "We are excited to see that tentative approval has been received so quickly. This reflects well on Novel's strong track record of bringing high-value generic products into the market."
Novel's President and CEO Veerappan S. Subramanian stated, "We are pleased to receive this tentative approval for a first launch generic, our second in a week, which completes our colon-cleansing product line. With Perrigo as a strategic partner, we will enhance our position in the generic pharmaceutical marketplace."
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