Alembic Pharmaceuticals has received USFDA final approval for Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg. These capsules are therapeutically equivalent to Dexilant Delayed-Release Capsules. Dexlansoprazole is a proton pump inhibitor used to treat conditions like erosive esophagitis, heartburn, and gastroesophageal reflux disease (GERD). The estimated market size for these capsules is US$ 285 million.
USFDA Approval Granted
Alembic Pharmaceuticals has announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dexlansoprazole Delayed-Release Capsules, in strengths of 30 mg and 60 mg. The announcement was made on November 13, 2025.
Product Details and Market Opportunity
The approved ANDA is therapeutically equivalent to Takeda Pharmaceutical’s Dexilant Delayed-Release Capsules. This medication, a proton pump inhibitor (PPI), is prescribed for patients 12 years and older. Indications include healing erosive esophagitis, maintaining healed esophagitis, relieving heartburn, and treating symptomatic non-erosive gastroesophageal reflux disease (GERD).
The market size for Dexlansoprazole Delayed-Release Capsules (30 mg and 60 mg) is estimated at US$ 285 million for the twelve months ending September 2025, according to IQVIA.
Alembic’s ANDA Approvals
With this approval, Alembic Pharmaceuticals now has a cumulative total of 229 ANDA approvals from the USFDA. This total consists of 209 final approvals and 20 tentative approvals.
Source: BSE
