Lupin clinches FDA approval for generic Spiriva HandiHaler

Indian pharma titan Lupin has announced receiving approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule.

This medication is a generic equivalent of Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder), an 18 mcg/capsule product of Boehringer Ingelheim Pharmaceuticals, Inc.

Lupin will manufacture this approved product at its Pithampur facility in India.

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

According to IQVIA MAT data as of March 2023, Tiotropium Bromide Inhalation Powder (Spiriva HandiHaler) had estimated annual sales of $1.26 billion in the US This approval marks a major step for Lupin in enhancing its global respiratory franchise.