Alembic Pharmaceuticals announced today that it has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dexlansoprazole Delayed-Release Capsules in 30 mg and 60 mg strengths. With this approval, Alembic can now market a therapeutically equivalent version of Dexilant, the reference product developed by Takeda Pharmaceuticals USA.
Dexlansoprazole is a proton pump inhibitor used in patients aged 12 years and above. It is prescribed for healing erosive esophagitis, maintaining the healing of erosive esophagitis and reducing heartburn, and managing symptomatic non-erosive gastroesophageal reflux disease. The company noted that the drug’s complete indication details are available on the approved label.
The market opportunity for Dexlansoprazole Delayed-Release Capsules in the US is estimated at around USD 285 million for the twelve months ending September 2025, based on IQVIA data.
Including this latest clearance, Alembic now holds a total of 229 ANDA approvals from the USFDA, comprising 209 final approvals and 20 tentative approvals. The steady pace of new approvals continues to strengthen the company’s position in the US generics market.
