Lupin Shares in Focus as US FDA Approves Eye Gel and Launches New Constipation Drug
Mumbai, July 2, 2025: Shares of pharmaceutical major Lupin are expected to remain in focus following two major positive developments – the US FDA approval for its Loteprednol Etabonate Ophthalmic Gel and the successful US launch of Prucalopride tablets for chronic constipation. These back-to-back approvals signal Lupin’s growing momentum in the US generics market and could influence Lupin share price positively in the coming sessions.
FDA Green Signal for Loteprednol Etabonate Eye Gel
Lupin announced that it has received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Loteprednol Etabonate Ophthalmic Gel, 0.38%. This drug is the generic version of Lotemax SM Ophthalmic Gel by Bausch & Lomb and is used in the treatment of inflammation and pain following eye surgery.
What makes this approval especially significant is that Lupin is the first-to-file applicant, granting it 180 days of generic drug exclusivity in the US market. According to IQVIA MAT data as of May 2025, the reference product has estimated annual sales of $29 million in the United States.
The newly approved eye gel will be manufactured at Lupin’s Pithampur facility in India, showcasing the company’s commitment to domestic production and global distribution.
Second Win: Prucalopride Tablets Launch for Constipation
Adding to the momentum, Lupin has also launched Prucalopride tablets (1 mg and 2 mg) in the US market after receiving final FDA approval. The drug, indicated for chronic idiopathic constipation (CIC) in adults, is a generic version of Motegrity tablets developed by Takeda Pharmaceuticals USA.
This launch opens doors to a significantly larger market. According to IQVIA data for April 2025, the US market size for Prucalopride tablets stands at an estimated $184 million annually. The tablets will be manufactured at Lupin’s Goa facility, strengthening the company’s operational footprint within India.
Impact on Lupin Share Price
With these dual approvals, Lupin’s growth narrative continues to strengthen. In the last trading session, Lupin share price closed at ₹1,961.3, up 1.2%. Despite a 17% year-to-date decline, the stock has delivered a stellar return of 117% over the past 12 months.
With a market capitalization of over ₹89,575 crore, Lupin remains a key player in India’s pharmaceutical sector. These FDA approvals could provide a near-term boost to investor sentiment and attract institutional interest, especially given the 180-day exclusivity on the eye gel.
Strategic Focus on US Market
The latest developments align with Lupin's strategy of expanding its presence in the US generics market, which continues to offer high-margin opportunities. By securing first-to-file exclusivity and launching drugs for niche conditions like CIC, Lupin positions itself ahead of the competition in terms of market capture and revenue growth.
Analyst View & Outlook
Market analysts believe that these approvals could be a catalyst for stock price recovery in the near term. The combination of a strong pipeline, timely FDA clearances, and cost-efficient manufacturing in India boosts Lupin’s profitability and long-term growth outlook.
Investors are closely watching whether the Lupin share price will break resistance levels in the coming weeks, especially with momentum building around new drug launches.
Conclusion
The dual milestones of FDA approval for Loteprednol Etabonate Gel and the US launch of Prucalopride tablets mark a pivotal phase in Lupin’s global growth strategy. These developments not only validate the company’s R&D capabilities but also reflect its efficient supply chain rooted in India.
As Lupin continues to make strategic strides in the US pharmaceutical market, both investors and healthcare professionals are likely to take note. The Lupin share price could soon reflect these growth triggers, making it a stock to watch closely in the pharma sector.
Disclaimer: This blog is for informational purposes only and does not constitute financial advice. Investors are advised to consult certified financial advisors before making investment decisions.
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