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Lupin Gets US FDA Nod For Loteprednol Gel With 180-Day Exclusivity

Synopsis:

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.

Also read: MOIL Hikes Prices Of Manganese Ore With Mn-44% And Above By 2 Percent

LUPIN LIMITED

Trade

1954.8-13.59 (-0.69 %)

Updated - 03 July 2025
1968.50day high
DAY HIGH
1937.90day low
DAY LOW
739865
VOLUME (BSE)

Key Takeaways

  • 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.

Also read: SBI Cards Faces GST Show Cause Notice Worth Rs.81.93 Crore

Recent Momentum In The US Market

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.

Market Overview

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.

Also read: RITES Wins $4.28 Million Order From Tsiko Africa For Locomotive Supply

Source: Money Control

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