Perrigo Company announced today that the Hatch-Waxman litigation relating to DuacGel (clindamycin phosphate (1 and benzoyl peroxide (5%) gel) filed by theStiefel Laboratories division of Glaxo SmithKline has been dismissed withprejudice. Earlier this year, KV Pharmaceuticals had been sued by Stiefel forinfringement of a patent related to KV’s filing of an Abbreviated New DrugApplication (ANDA) for a generic to Duac Gel in the United States DistrictCourt for the District of Delaware. In September 2009 Perrigo acquired allrights in the KV Pharmaceutical’s ANDA. Perrigo’s Chairman and CEO Joseph C. Papa stated, “This is another exampleof Perrigo’s commitment to continue bringing new topical generic products tothe market at the earliest possible entry date. Perrigo is working every dayto make quality healthcare more affordable.” This product is the AB-rated equivalent to Stiefel Laboratories’ Duacgel, indicated for the topical treatment of inflammatory acne vulgaris. Annualsales for the brand were approximately $165 million according to WoltersKluwer data. The dismissal of the lawsuit ends the 30 month Hatch-Waxman stayperiod, which was originally set to expire towards the end of 2011. Uponreceiving final regulatory approval, Perrigo expects to launch this product.
