US Pharm. 2010;35(6)(Generic Drug Review suppl):42.
Perrigo Company and Graceway Pharmaceuticals, LLC, announced that they have entered into an agreement to settle all existing patent litigation regarding Perrigo’s Abbreviated New Drug Application (ANDA) filing No. 78-837, or generic imiquimod. As part of this agreement, Perrigo will be named Graceway’s authorized generic distributor for Aldara (imiquimod) 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 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 aged 12 years or older.
