Mylan NV, a global pharmaceutical company, and its two subsidiaries-- Mylan Pharmaceuticals Inc. and Mylan Technologies Inc have been sued by Noven Pharmaceuticals Inc and Hisamitsu Pharmaceutical Co, Inc, in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Estradiol Transdermal System, USP, twice-weekly 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day.
This product is the generic version of Minivelle, which is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and the prevention of postmenopausal osteoporosis.
Mylan chief executive officer Heather Bresch said "Our ANDA for a generic Minivelle is one of six Mylan applications for transdermal products pending FDA approval, representing USD 3.6 billion in annual sales. Mylan currently markets seven transdermal product families in the US, of which three form part of our women's health portfolio, and we look forward to continue expanding access to high quality medicines for patients in this space."
Mylan believes that it is the first company, or among the first companies, to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval. The plaintiffs filed suit against the Mylan companies in the United States district court in the district of Delaware.
For the 12 months ending February 2015, Minivelle had US sales of approximately USD 115 million, according to IMS Health.
Currently, Mylan has 273 ANDAs pending FDA approval representing USD 106.9 billion in annual sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing USD 31.1 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.