Granules India gets USFDA nod for generic pantoprazole sodium tablets

Granules India Ltd on Wednesday said it has received approval from the US health regulator for its generic pantoprazole sodium delayed-release tablets used in the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease.

The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for pantoprazole sodium delayed-release tablets of strengths 20 mg and 40 mg, Granules India said in a regulatory filing.

It is bioequivalent and therapeutically equivalent to the reference listed drug, Protonix Delayed-Release Tablets, 20 mg and 40 mg strengths, of Wyeth Pharmaceuticals LLC, it added.

Pantoprazole sodium delayed-release tablets are indicated for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD) -- a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus.

The medicine is also used for the maintenance of healing of erosive esophagitis and pathological hypersecretory conditions, including Zollinger-Ellison (ZE) syndrome, it added.

The current annual US market for pantoprazole tablets is approximately USD 233 million, the company said citing IQVIA/IMS Health, MAT Oct 2023 data.