Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). The approved product is therapeutically equivalent to Protonix I.V. for Injection, 40 mg/vial, developed by Wyeth Pharmaceuticals LLC.
Pantoprazole sodium for injection is indicated for the treatment of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. It is also indicated for the treatment of pathological hypersecretion conditions, including Zollinger-Ellison Syndrome in adults.
According to IQVIA, the estimated market size for Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial), for the twelve months ending December 2024 is approximately $48 million.
Alembic Pharmaceuticals now holds a total of 221 ANDA approvals from the USFDA, comprising 195 final approvals and 26 tentative approvals.