Watson Pharmaceuticals, Inc., a global, integrated speciality pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products, has announced that its subsidiary Watson Laboratories, Inc. – Florida has received approval from the US Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for tranexamic acid tablets, the generic equivalent to Ferring Pharmaceuticals' Lysteda.
Watson intends to begin shipping the product immediately. Lysteda is indicated for the treatment of cyclic heavy menstrual bleeding. Ferring B.V. has filed lawsuits against Watson, alleging that Watson's ANDA product infringes US Patent Nos. 7,947,739, 8,022,106, and 8,273,795. The litigations remain pending.
For the 12 months ended November 30, 2012, Lysteda had total US sales of approximately $25 million according to IMS Health data.
Watson is the world's third-largest generics prescription drug manufacturer, with more than 750 products marketed globally through operations in more than 60 countries. Watson's global branded pharmaceutical business develops and markets products principally in urology and women's health, and is committed to developing and marketing biosimilars products in women's health, oncology and other therapeutic categories.