Lupin obtains FDA nod for generic Spiriva HandiHaler

Lupin has received the Food and Drug Administration’s permission for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, which is a generic of Boehringer Ingelheim’s Spiriva HandiHaler.

The medication is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema, and to reduce exacerbations in COPD patients.

The company will manufacture the product at its Pithampur facility in India.

[Read more: Camber releases generic Daliresp]

“We are delighted to receive the final approval for generic Spiriva HandiHaler from the U.S. FDA.," said Vinita Gupta, CEO of Lupin. "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 United States, and also is the first DPI approval from India for the United States. This is an important milestone in our journey of building our respiratory franchise globally.”

[Read more: Aurobindo receives FDA OK for generic Letairis]

Tiotropium Bromide Inhalation Powder (Spiriva HandiHaler) had a market value of roughly $1.3 billion, per March 2023 IQVIA data.