Dr. Reddy's gets FDA nod for orally disintegrating lansoprazole 

A Dr. Reddy's facility (Dr. Reddy's Laboratories)

Dr. Reddy’s Laboratories has introduced an orally disintegrating formulation of lansoprazole to the U.S. market. The new product is the therapeutic equivalent of the Prevacid SoluTab delayed-release tablets sold by Takeda.

Lansoprazole is a proton pump inhibitor, a mechanism of action designed to reduce the amount of acid made in the stomach and thereby treat conditions including indigestion, heartburn, acid reflux and gastroesophageal reflux disease. Researchers developed an orally disintegrating form of the active ingredient in the early 2000s as a convenient option that can be taken without water. 

TAP Pharmaceuticals, then a joint venture between Abbott and Takeda, won FDA approval for an oral disintegrating form of the drug in 2002. Since then, Mylan, Teva Pharmaceutical and Zydus Pharmaceuticals have received FDA nods, although the early impact on Prevacid was reduced by patient rows and product withdrawals. 

Now, Dr. Reddy’s has become the fifth company to win FDA clearance to sell an orally disintegrating formulation of lansoprazole in the U.S. Dr. Reddy’s, like its rivals for the space, is authorized to sell 15-mg and 30-mg versions of the product. 

The five companies are competing for a relatively small market. In disclosing its entry to the market, Dr. Reddy’s quoted an IQVIA analysis that put U.S. sales of branded and generic Prevacid in the 12 months up to December 2020 at around $87 million. 

Dr. Reddy’s has experience of the broader lansoprazole market. Around a decade ago, the Indian drugmaker ran a bioequivalence study of a delayed-release lansoprazole formulation and went on to win FDA approval for an over-the-counter product based on the ingredient.