Glenmark Pharmaceuticals Gains FDA Approval for Generic Otezla Tablets

17 Oct 2023 , 11:50 AM

Glenmark Pharmaceuticals Ltd. has received final approval from the U.S. FDA for Apremilast Tablets in 10 mg, 20 mg, and 30 mg strengths, which are the generic equivalents of Amgen Inc.’s Otezla Tablets in the same strengths.

The IQVIA sales data for the 12 months ending in August 2023 reports that the market for Otezla Tablets achieved approximately $3.7 billion in annual sales. Glenmark Pharmaceuticals holds a portfolio of 188 products authorized for distribution in the U.S. market, along with 50 ANDA applications awaiting approval from the U.S. FDA.

In the first quarter of FY 24, the Mumbai-based pharmaceutical company saw a 22 %decline in net profit, which amounted to Rs 150 crore. Notably, Glenmark Pharma made headlines by selling 75 %of its subsidiary, Glenmark Lifesciences, to Nirma for Rs 5,651 crore.

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