Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Sodium Phenylbutyrate Tablets USP, 500 mg, the generic version of Buphenyl®1 Tablets, 500 mg, of Horizon Therapeutics, LLC. Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.

According to IQVIATM sales data for the 12-month period ending September 2022, the Buphenyl® market2 achieved annual sales of approximately $8.7 million.

Glenmark’s current portfolio consists of 177 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.