Teva Pharmaceuticals said that it has launched a generic version of Perforomist formoterol fumarate inhalation solution for the treatment of COPD in the US. Perforomist was approved by the FDA in 2007; Teva first submitted an ANDA for its generic inhalation solution in 2009; the Teva ANDA was tentatively approved in May 2020; and Mylan’s covering Perforomist expired on June 22, 2021.
In 2013, a US court found that Teva’s formoterol fumarate inhalation solution infringed on a Mylan patent covering Perforomist, and in 2014, the court upheld all of the Mylan patents covering Perforomist. In 2015, an appeals court upheld the 2014 ruling.
Teva USA Senior VP and Chief Operating Officer, US Generics, Christine Baeder commented, “Teva is pleased to provide patients with first-to-market access to a generic version of Perforomist formoterol fumarate inhalation solution.”
Read the Teva press release.
