Lupin Launches First Generic Pred Forte® Ophthalmic Suspension in the U.S.
Prednisolone Acetate Ophthalmic Suspension Marks First Generic Launch with 180-Day CGT Exclusivity
Mumbai, Naples, October 15, 2024: Lupin Limited, a global pharmaceutical company, announced the launch of the first generic version of Pred Forte® (Prednisolone Acetate) Ophthalmic Suspension USP, 1% in the United States. With this launch, Lupin is granted 180-day competitive generic therapy (CGT) exclusivity, as it is the first generic approved for this formulation.
The generic Prednisolone Acetate Ophthalmic Suspension USP, 1% serves as an equivalent to AbbVie Inc.’s Pred Forte® Ophthalmic Suspension, 1%. It is indicated for the treatment of steroid-responsive inflammation in the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye. Pred Forte® had annual U.S. sales of approximately $198 million as of August 2024 (IQVIA MAT data).
Vinita Gupta, CEO of Lupin, stated, “The launch of Prednisolone Acetate Ophthalmic Suspension represents a significant milestone in our ongoing efforts to provide affordable and high-quality healthcare solutions. This addition to our ophthalmic portfolio will greatly benefit patients in need of effective treatments for steroid-responsive inflammation.”
About Lupin
Headquartered in Mumbai, India, Lupin Limited is a leading global pharmaceutical company, with a presence in over 100 markets. The company offers a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin holds strong market positions in the U.S. and India across several therapeutic areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.
The company operates 15 advanced manufacturing facilities and seven research centers worldwide and employs over 22,000 professionals. Lupin is dedicated to improving patient health outcomes through its subsidiaries—Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
