According to Lannett, the company has acquired US rights to market Respirents generic of Spiriva Handihaler tiotropium bromide DPI for a 10-year period, the company said. Lannett had already acquired US rights to Respirent’s generic versions of Advair Diskus in 2019 and Flovent Diskus in 2020.
Lannett CEO Tim Crew commented, “We continue to add drug and device combination respiratory medications to our pipeline. We believe such products provide durable sales opportunities with relatively fewer competitors, due to the technical expertise, specialized manufacturing and financial commitment required to develop these products. With generic Spiriva Handihaler, our strategic relationship with Respirent now includes three inhaler products, each of which has the potential to be a meaningful contributor to our company’s financial performance. The generic Spiriva Handihaler product is currently in development and tracking to Abbreviated New Drug Application (ANDA) submission in 2023.”
In April 2021, the company announced the submission of an ANDA for the generic fluticasone propionate / salmeterol xinafoate DPI , and the FDA has set a PDUFA goal date for completion of its review of the application for January 31, 2022. Submission of an ANDA for the generic fluticasone propionate DPI is expected in 2022, the company said.
Read the Lannett press release.
