Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the company’s Abbreviated New Drug Application (ANDA) to market its generic version of Wyeth’s Protonix ®, pantoprazole tablets.

These generic pantoprazole tablets are AB-rated equivalent of Wyeth’s Protonix ® Delayed Release Tablets and include two strengths: 20 mg (base) and 40 mg (base). These strengths of Protonix® have annual sales of approximately USD 2.3 billion in the US.

Sun Pharma, being one of the first-to-file an ANDA for generic Protonix® with a para IV certification, shares a 180-day marketing exclusivity.

Pantoprazole is indicated for short term treatment of erosive esophagitis associated with GERD, maintenance of healing of erosive esophagitis and for treatment of hypersecretory conditions.

The Company is currently evaluating its launch options.

PROTONIX ® is a registered trademark of Wyeth Pharmaceuticals Inc 

Sourced From: Sun Pharmaceutical Industries Ltd