Lupin Gains US FDA Approval for Generic Mirabegron to Treat Overactive Bladder
核心洞察
Lupin has received US FDA approval for its generic version of Mirabegron extended-release tablets (50 mg) used to treat overactive bladder (搜索).
The generic drug is an equivalent to Astellas Pharma's Myrbetriq, with estimated annual sales of $1.6 billion in the US.
Lupin and Zydus are the only companies with approval for both 25 mg and 50 mg strengths, potentially securing a six-month exclusivity period.
Lupin's share price surged, reaching a 52-week high, after the global pharmaceutical company announced the US FDA approval of its generic version of Mirabegron extended-release tablets (50 mg) for the treatment of overactive bladder (搜索). This approval positions Lupin to compete in a market with substantial annual sales.
The company's regulatory filing confirmed the approval of the 50 mg strength of Mirabegron extended-release tablets. This generic medication is an equivalent to Astellas Pharma Global Development's Myrbetriq. According to IQVIA MAT July 2024 data, the estimated annual sales for Mirabegron in the US are $1.6 billion.
Market Dynamics and Exclusivity
ICICI direct Research noted that Lupin and Zydus are the only companies currently approved for both the 25 mg and 50 mg strengths of the drug. The report suggests that Lupin and Zydus could benefit from a six-month exclusivity period, as other players are unlikely to enter the market before court resolution of ongoing litigation.
Lupin's Recent Launches
Lupin also recently launched single-dose vials of doxorubicin hydrochloride liposome injection in the US, in collaboration with ForDoz Pharma Corporation, USA, following US FDA clearance.
Stock Performance
On Thursday, Lupin's share price opened at ₹2,289.90 on BSE, reaching an intraday high of ₹2,306.85. Ruchit Jain, Lead Research Analyst at 5paisa, noted the stock's positive trend, stating, "Lupin share price has seen rising volumes during recent upmove. The volumes are low on corrections and stock has good support around ₹2,140 which is the 20 DEMA support. Thus, downside seems to be limited for the short term."
Trendlyne data indicates that Lupin's stock price has increased by 109.96% over the past year, outperforming its sector by 40.9%. This performance reflects strong investor confidence in the company's growth and strategic initiatives.