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Lupin has received US FDA approval for its loteprednol etabonate ophthalmic gel, 0.38%, with 180-day exclusivity. The product sees estimated US sales of $29 million.
Pharmaceutical major Lupin Ltd has received approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for loteprednol etabonate ophthalmic gel, 0.38%. This product is a generic version of Lotemax SM ophthalmic gel, originally developed by Bausch & Lomb Inc. With this approval, Lupin will be the first generic manufacturer to enter the market with a 180-day exclusivity period.
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Product: Loteprednol etabonate ophthalmic gel, 0.38%
Purpose: Treats inflammation and pain after ocular surgery
US Market Size: Estimated at $29 million (IQVIA MAT May 2025)
Exclusivity: 180-day first-to-file advantage
Manufacturing Site: Pithampur facility, India
Lupin share price: Rose 1.56% to Rs.1,968 post-announcement
The corticosteroid gel is used to manage post-operative inflammation and discomfort following ocular procedures. Lupin’s approval also gives it a crucial edge in the competitive US generics market due to its first-to-file status, granting it a temporary monopoly for six months. This exclusivity window often allows higher initial revenue generation.
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This FDA approval follows another milestone last week when Lupin launched prucalopride tablets in the United States. These tablets, available in 1 mg and 2 mg strengths, are used to treat chronic idiopathic constipation (CIC) in adults. Lupin’s prucalopride tablets are bioequivalent to Motegrity by Takeda Pharmaceuticals U.S.A., Inc., and will be produced at the company’s Goa facility.
The prucalopride tablets cater to a much larger estimated US market of $184 million, based on IQVIA MAT data for April 2025. These back-to-back approvals strengthen Lupin’s foothold in the US generics space and could support growth in overseas revenue segments.
Product Name | Market Size (US) | Manufacturing Facility | Exclusivity |
Loteprednol etabonate gel (0.38%) | $29 million | Pithampur | 180 days |
Prucalopride tablets (1 mg, 2 mg) | $184 million | Goa | None |
Lupin share price ended the day at Rs.1,968 on the BSE, gaining Rs.30.20 or 1.56 percent. The stock has shown resilience amid broader market volatility and continues to react positively to regulatory milestones. The recent developments are likely to support short-term momentum in the Lupin share price.
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Source: Money Control
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