Lupin has launched its generic version of Spiriva HandiHaler tiotropium bromide DPI for the treatment of COPD in the US, the company said. The FDA approved Lupin’s ANDA for the tiotropium bromide inhaler in June 2023. The generic of Spiriva HandiHaler was recently approved in Australia and has also been approved in the UK and Canada.
Lupin CEO Vinita Gupta commented, “We are delighted to announce the launch of generic Spiriva HandiHaler in the US, the first generic to this important drug for COPD. This launch is a testament to our commitment to advancing healthcare accessibility and is a result of years of hard work and dedication to building our complex products and respiratory franchise. Being the first to bring an FDA-approved generic version of Spiriva in the US further reaffirms our commitment to enhancing the well-being of COPD patients for a healthier future.”
Read the Lupin press release.