Mumbai, Nov. 13 -- The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Dexilant Delayed-Release Capsules, 30 mg and 60 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda).

Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for use in patients 12 years of age and older for the healing of all grades of erosive esophagitis (EE), the maintenance of healed EE and relief of heartburn, as well as the treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD).

Dexlansoprazole Delayed-Release Capsules (30 mg and 60 mg) have an estimated market size of $285 million for the twelve months ending September 2025, according to IQVIA.

With this approval, Alembic now holds ...