Lupin receives U.S. FDA approval for Brimonidine Tartrate Ophthalmic Solution

Lupin has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brimonidine Tartrate Ophthalmic Solution, 0.1 per cent, to market a generic equivalent of Alphagan P Ophthalmic Solution, 0.1 per cent, of AbbVie Inc. This product will be manufactured at Lupin’s Pithampur facility in India.

Brimonidine Tartrate Ophthalmic Solution, 0.1 per cent is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. 

Brimonidine Tartrate Ophthalmic Solution (RLD Alphagan P) had an estimated annual sales of USD 178.5 million in the U.S. (IQVIA MAT June 2024).