Glenmark gets US FDA approval for Theophylline ER Tablets, 300 mg and 450 mg

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Theophylline Extended-Release Tablets, 300 mg and 450 mg, bioequivalent and therapeutically equivalent to the reference listed drug, Theophylline Extended-Release Tablets, 300 mg and 450 mg, of Alembic Pharmaceuticals.

Glenmark has been granted a competitive generic therapy (CGT) designation for Theophylline Extended-Release Tablets USP, 450 mg. With this approval, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing of the 450 mg strength.

According to IQVIA sales data for the 12 month period ending April 2021, the Theophylline Extended-Release Tablets, 300 mg and 450 mg market achieved annual sales of approximately $47.8 million*.

Glenmark’s current portfolio consists of 173 products authorised for distribution in the US marketplace and 44 ANDAs pending approval with the US FDA.