Lupin gains FDA approval for generic Toprol-XL Tablets

Lupin Limited, a dominant player in the global pharmaceutical landscape, announced its triumph in obtaining the coveted approval from the United States Food and Drug Administration (FDA). This authorization is for Lupin’s Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-Release Tablets USP in the concentrations of 25 mg, 50 mg, 100 mg, and 200 mg. This positions Lupin to market the generic counterpart of Toprol-XL Tablets produced by Sequel Therapeutics, LLC in similar dosages.

These Metoprolol Succinate Extended-Release Tablets, paralleling the Reference Listed Drug (RLD) Toprol-XL, have witnessed robust annual sales, estimated at a whopping $305 million in the U.S. market alone, as per data from IQVIA MAT up till June 2023.

The strategic manufacturing of this approved product will be undertaken at Lupin’s state-of-the-art Pithampur facility situated in India. This achievement not only amplifies Lupin’s commitment to offering quality healthcare solutions but also further cements its position in the U.S. generic pharmaceutical market.