Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, a generic equivalent of Spiriva® HandiHaler® (Tiotropium Bromide Inhalation Powder), 18 mcg/capsule of Boehringer Ingelheim Pharmaceuticals, Inc. 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 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,” said Vinita Gupta, CEO, Lupin.
Tiotropium Bromide Inhalation Powder (Spiriva® HandiHaler®) had estimated annual sales of USD 1,264 million in the U.S. (IQVIA MAT Mar 2023).
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