BRIEF—FDA nod for Lupin's Spiriva HandiHale generic

Indian drugmaker Lupin Limited has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for tiotropium bromide inhalation powder, 18 mcg/capsule, a generic equivalent of German pharma major Boehringer Ingelheim’s Spiriva HandiHale.

This product will be manufactured at Lupin’s Pithampur facility in India.

“We are delighted to receive the final approval for generic Spiriva HandiHaler from the US FDA. This builds on our commitment to serving unmet needs for our patients across the world. This is the first generic approval for Spiriva HandiHaler in the USA, and is also the first DPI approval from India for the US. This is an important milestone in our journey of building our respiratory franchise globally,” said Lupin’s chief executive Vinita Gupta.

According to IQVIA data, Spiriva HandiHaler had estimated annual sales of $1,264 million in the USA for the 12 months ended March 2023.