Glenmark Pharmaceuticals secures FDA approval for generic version of Otezla Tablets

Glenmark Pharmaceuticals Ltd. has successfully secured the final approval from the United States Food & Drug Administration (U.S. FDA) for its Apremilast Tablets in 10 mg, 20 mg, and 30 mg dosages. This approval allows Glenmark to market the generic counterpart of Amgen Inc.’s Otezla Tablets.

Recent IQVIA sales figures reveal that the market for Otezla® Tablets (10 mg, 20 mg, and 30 mg) witnessed staggering annual sales close to $3.7 billion for the 12-month span concluding in August 2023.

A Glimpse at Glenmark’s Growing U.S. Portfolio

With this significant milestone, Glenmark’s product portfolio in the U.S. now comprises 188 FDA-sanctioned products. Additionally, Glenmark awaits the U.S. FDA’s decision on 50 Abbreviated New Drug Applications (ANDA). Beyond these internal endeavors, the pharmaceutical giant is actively seeking external partnerships, aiming to reinforce and expedite its existing pipeline’s growth and breadth.