PITTSBURGH — Mylan on Monday announced the U.S. District Court for the Northern District of West Virginia ruled in favor of upholding the validity of patents protecting Perforomist (formoterol fumarate) Inhalation Solution. Mylan previously sued Teva alleging that Teva's abbreviated new drug application for this product infringed four Mylan patents covering Perforomist.
The court's decision prevents Teva's ANDA, which has yet to receive a tentative approval from the Food and Drug Administration.
"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," said Mylan CEO Heather Bresch. "We are excited about the growth of our respiratory franchise and look forward to continuing to meet unmet needs in this increasingly important space."