Glenmark Pharmaceuticals gets FDA final approval for Buphenyl generic

Glenmark Pharmaceuticals said that it has bagged final approval for Sodium Phenylbutyrate Tablets USP, 500 mg by the US Food and Drug Administration (FDA).

The approved product is a generic version of Buphenyl Tablets (sodium phenylbutyrate), 500 mg, of Horizon Therapeutics and is indicated for the treatment of urea cycle disorders.

According to Glenmark Pharmaceuticals, the distribution of Sodium Phenylbutyrate Tablets USP, 500 mg in the US will be undertaken by its subsidiary — Glenmark Pharmaceuticals Inc., USA.

Buphenyl is estimated to have annual sales of around $8.7 million in the US, as per sales data from IQVIA for the 12 months ended September 2022.

The current portfolio of Glenmark Pharmaceuticals includes 177 products that have distribution authorization in the US marketplace and 46 pending approvals of abbreviated new drug applications (ANDAs) with the FDA.