According to Mylan, the United States District Court for the Northern District of West Virginia has upheld the validity of all of its patents related to Perforomist formoterol fumarate inhalation solution. The company says that the ruling will prevent the FDA from approving Teva’s ANDA for its formoterol fumarate inhalation solution before expiration of patents 6,667,344; 6,814,953; 7,348,362; and 7,462,645. The patents extend through June 2021.
Mylan CEO Heather Bresch said, “The court’s decision to recognize the validity of the patents covering Mylan’s Perforomist inhalation solution not only affirms the strength of our intellectual property on this product, but also our broader respiratory portfolio, including Mylan’s combination product currently in development. We are excited about the growth of our respiratory franchise and look forward to continuing to meet unmet needs in this increasingly important space.”
Read the Mylan press release.