Perrigo Company and Graceway Pharmaceuticals, LLC, have entered into an agreement to settle all existing patent litigation regarding Perrigo’s ANDA filing No. 78-837 or generic imiquimod. As part of this agreement, Perrigo will be named Graceway’s authorized generic distributor for the Aldara product through February 24, 2011 and, under certain circumstances, will be able to launch its own generic product after that date. Perrigo will begin shipping the authorized generic product within the next few weeks.
Aldara (imiquimod) Cream 5% is indicated for the topical treatment of actinic keratoses on the face or scalp, superficial basal cell carcinoma, and external genital and perianal warts in patients 12 years old or older. Aldara had sales of approximately $370 million for the 12 months ended February 2010, as measured by Wolters Kluwer Health.
Perrigo’s Chairman and CEO Joseph C. Papa concluded, “This agreement reflects our continuing investment in new products. Our generic pharmaceutical division is committed to participate in all new products in our extended topical category. As always, Perrigo is committed to making quality healthcare more affordable for our customers and drive value for our shareholders.”
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products.