Lupin Limited has received approval from the U.S. FDA for its Prednisolone Acetate Ophthalmic Suspension USP, 1%, a generic version of AbbVie’s Pred Forte. This approval comes with a Competitive Generic Therapy (CGT) designation, granting Lupin 180 days of market exclusivity as the first approved applicant. Manufactured at Lupin’s Pithampur facility in India, the suspension is used to treat steroid-responsive inflammation of the eye. Pred Forte had estimated annual sales of $198 million in the U.S. as of June 2024, according to IQVIA.
