Mylan Inc. announced the U.S. launch of its Estradiol Transdermal System USP, which is the generic version of Novartis’ Vivelle-DOT. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar and vaginal atrophy due to menopause; hypoestrogenism due to hypogonadism, castration or primary ovarian failure; and the prevention of postmenopausal osteoporosis.(1)
Mylan CEO Heather Bresch commented: “The approval of Mylan’s Estradiol Transdermal System USP represents our seventh U.S. transdermal product launch and strengthens the company’s growing portfolio of women’s health products. We look forward to continuing to meet patient needs in this space as we strive to provide the world’s 7 billion people access to high quality medicines.”
Estradiol Transdermal System USP had U.S. sales of approximately $262.5 million for the 12 months ending September 30, 2014, according to IMS Health.
Currently, Mylan has 285 ANDAs pending FDA approval representing $111.3 billion in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.