Lupin gets USFDA approval for Tiotropium Dry Powder Inhaler

21 Jun 2023 , 02:46 PM

Lupin Limited announced that the United States Food and Drug Administration (USFDA) has granted approval for its Abbreviated New Drug Application for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule. It is a generic equivalent of Boehringer Ingelheim Pharmaceuticals, Inc.’s Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder), 18 mcg/capsule.

Lupin’s Pithampur facility in India will manufacture this product.

Vinita Gupta, the CEO of Lupin, expressed great satisfaction with the recent approval received from the USFDA for the generic version of Spiriva HandiHaler. This approval reinforces their dedication to addressing the unmet requirements of patients worldwide. 

It is noteworthy that this is the first approval for a generic version of Spiriva HandiHaler in the U.S., and it also marks the first approval of a Dry Powder Inhaler (DPI) from India for the U.S. market. The company considers this a significant achievement in their efforts to establish a strong respiratory franchise on a global scale.

In the United States, Tiotropium Bromide Inhalation Powder (Spiriva HandiHaler) had an estimated annual sales of USD 1,264 million (IQVIA MAT Mar 2023).

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