Alembic receives USFDA approval for Dexlansoprazole delayed-release capsules

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg.

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 in patients 12 years of age and older for: (i) healing of all grades of erosive esophagitis (EE), (ii) maintenance of healed EE and relief of heartburn, and (iii) treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). Refer label for a detailed indication.

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

Alembic has a cumulative total of 229 ANDA approvals, including 209 final approvals and 20 tentative approvals, from the USFDA.