Glenmark Pharmaceuticals gets FDA approval for generic Protopic Ointment

Glenmark Pharmaceuticals Ltd., a global leader in pharmaceutical research, has secured the final nod from the U.S. Food & Drug Administration (U.S. FDA) for its Tacrolimus Ointment, 0.03%. This ointment stands as the generic counterpart to Leo Pharma AS’s Protopic Ointment, 0.03%. Marking its entry into the U.S. market, the product will be distributed by Glenmark’s American subsidiary, Glenmark Pharmaceuticals Inc., USA.

Recent sales data from IQVIA indicates that the Protopic Ointment 0.03% market grossed an impressive annual sales figure of around $15.4 million as of June 2023. With this approval, Glenmark strengthens its position in the U.S. pharmaceutical landscape. Currently, the company boasts a portfolio of 184 FDA-approved products available for U.S. distribution, complemented by an additional 51 Abbreviated New Drug Applications (ANDA’s) awaiting U.S. FDA approval. Beyond its internal ventures, Glenmark remains committed to fostering external partnerships, aiming to bolster and expedite its existing product pipeline and growth trajectory.