Lupin Limited (Lupin), a global pharma major announced its approval from the United States Food and Drug Administration (U.S. FDA), today 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.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas.
Vinita Gupta, CEO of Lupin 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.” The Tiotropium Bromide Inhalation Powder(Spiriva®HandiHaler®) had estimated annual sales of USD 1,264million in the U.S.
In March quarter earnings call, Lupin mentioned about it being in active dialogue with the US health regulator and that the Target Action Date (TAD) for gSpiriva is now in July 2023, albeit without an inspection. The drugmaker was hopeful of getting approval for gSpiriva soon and the regulator approved the Drug Master File (DMF) for gSpiriva in the first week of May, according to the management. According to the company’s management, the possibility of a Complete Response Letter is very low.
Antique Stock Broking estimates that the gross market size for gSpiriva (respiratory and handihaler) is said to be worth $1 billion. The firm also said that Lupin’s revival of margins and profitability is largely linked to key launches. Shares of Lupin are now at the day’s high, trading 4.3 percent higher at Rs 867.30. The stock is trading at the highest level in 16 months and has witnessed a rise of 15 percent so far on a year-to-date basis.
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