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Lupin, a leading global pharmaceutical company, saw its stock surge by over 1% on Thursday, reaching a 52-week high. This spike followed the launch of its generic version of Mirabegron extended-release tablets in the U.S., used to treat overactive bladder (OAB). The approval from the USFDA–U.S. Food and Drug Administration has made Lupin a focal point for investors looking to invest in stocks within the pharmaceutical sector.

USFDA approval for Mirabegron tablets

Lupin’s newly approved Mirabegron extended-release tablets are a generic equivalent of Astellas Pharma Global’s Myrbetriq, with a 50 mg strength available. According to July 2024 IQVIA data, this product taps into a U.S. market worth USD 1.6 billion annually. The drug’s approval marks a key milestone for Lupin, opening up substantial revenue potential. For those planning to invest in stocks, this development adds to Lupin's attractiveness in the pharmaceutical space.

Shared opportunity with Zydus

While Lupin isn’t the only company entering this market—Zydus also gained approval for both 25 mg and 50 mg Mirabegron tablets—both companies are currently navigating ongoing litigation over the drug. Despite this, Lupin and Zydus will benefit from a six-month exclusivity period before other competitors enter the market. This exclusivity allows Lupin to strengthen its foothold in the U.S. and provides a revenue boost, making it appealing for those looking to invest in stocks.

Additional USFDA approval: Doxorubicin hydrochloride

In addition to Mirabegron, Lupin announced the launch of single-dose vials of doxorubicin hydrochloride liposome injection in collaboration with ForDoz Pharma Corporation, USA. This cancer treatment drug, now available in the U.S., is expected to bolster Lupin’s presence in the oncology segment, expanding its market share.

Lupin’s stock performance

During Thursday's trading session, Lupin’s share price opened at ₹2,289.90 on BSE, hitting a high of ₹2,306.85. Despite minor fluctuations, the stock has maintained its upward trajectory. Ruchit Jain, Lead Research Analyst at 5paisa, highlighted Lupin's rising volumes, indicating strong support around ₹2,140 (20-Day Exponential Moving Average). This suggests a limited downside risk, positioning Lupin as a favourable choice for investors aiming to invest in stocks.

Key takeaways

  • Lupin’s stock hit a 52-week high after launching its generic Mirabegron tablets in the U.S.
  • The U.S. market for Mirabegron is valued at USD 1.6 billion annually, presenting a lucrative revenue opportunity.
  • Both Lupin and Zydus will enjoy six months of market exclusivity.
  • Lupin also launched doxorubicin hydrochloride liposome injection in the U.S., expanding its oncology portfolio.
  • Lupin’s stock shows strong support at ₹2,140, offering limited downside risk for investors in stocks.