ALLEGAN, MICH - Perrigo Company announced in a press release that the Hatch-Waxman litigation relating to Duac Gel (clindamycin phosphate (1%) and benzoyl peroxide (5%) gel) filed by the Stiefel Laboratories division of Glaxo SmithKline has been dismissed with prejudice.
Earlier this year, KV Pharmaceuticals had been sued by Stiefel for infringement of a patent related to KV’s filing of an Abbreviated New Drug Application (ANDA) for a generic to Duac Gel in the US District Court for the District of Delaware. In September 2009 Perrigo acquired all rights in the KV Pharmaceutical’s ANDA.
“This is another example of Perrigo’s commitment to continue bringing new topical generic products to the market at the earliest possible entry date. Perrigo is working every day to make quality healthcare more affordable,” Perrigo’s Chairman and CEO Joseph C. Papa stated.
This product is the AB-rated equivalent to Stiefel Laboratories’ Duac gel, indicated for the topical treatment of inflammatory acne vulgaris. Annual sales for the brand were approximately $165 million according to Wolters Kluwer data.
The dismissal of the lawsuit ends the 30 month Hatch-Waxman stay period, which was originally set to expire towards the end of 2011. Upon receiving final regulatory approval, Perrigo expects to launch this product.
The Company expects this launch to have 180 day first-to-file exclusivity.
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.
