NEW YORK — Teva Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories and Sandoz Inc. have announced generic versions of Takeda Pharmaceutical’s Prevacid (lansoprazole) antacid.
Israel-based Teva on Monday said it has received approval by the Food and Drug Administration for its Abbreviated New Drug Application (ANDA) to market a generic version of Prevacid SoluTab orally disintegrating tablets (ODTs) and that it has begun shipping the product.
Teva reported that annual U.S. sales of Prevacid were approximately $453 million, according to data from IMS Health.
Meanwhile, India-based Dr. Reddy’s said Monday that it soon plans to ship lansoprazole delayed-release capsules in 15-mg and 30-mg dosages, a bioequivalent generic version of Prevacid Delayed-Release Capsules, in the U.S. market. The FDA granted approval for the product late last week, the company said.
Dr. Reddy’s lansoprazole delayed-release capsules will be available in 30- and 90-count bottles for the 15-mg dose and in 90- and 500-count bottles for the 30-mg dose.
Also on Monday, Novartis subsidiary Sandoz said it has introduced an authorized generic equivalent of Prevacid SoluTab ODTs in the United States.
Sandoz plans to market lansoprazole in 15-mg and 30-mg strength delayed-release ODTs, the same strengths marketed for Prevacid SoluTab. Sandoz also markets lansoprazole delayed-release capsules, an authorized generic of Prevacid Delayed-Release Capsules, in the same strengths.
"Sandoz US is pleased to launch our authorized generic version of the popular Prevacid SoluTab," stated Don DeGolyer, president of Sandoz Inc., Princeton, N.J. "This launch expands our product line to include all strengths and formulations of prescription Prevacid and demonstrates Sandoz’s commitment to meeting patient needs by providing a convenient, orally disintegrating tablet formulation."
Lansoprazole is a proton pump inhibitor indicated for the treatment of active duodenal and gastric ulcers and the common symptoms of gastroesophageal reflux disease (GERD), including heartburn and erosive esophagitis. Sandoz reported that research estimates that as many as 60 million Americans suffer from GERD.
