Lupin gains FDA approval for generic Pitavastatin Tablets, targeting $298m market

Global pharmaceutical giant Lupin Limited announced its receipt of approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Pitavastatin Tablets in 1 mg, 2 mg, and 4 mg dosages. These tablets are set to be a generic equivalent of Livalo Tablets by Kowa Company Limited, offering a new option in the cholesterol management drug market.

Manufacturing at Lupin’s Pithampur Facility

The approved product, destined for the U.S. market, will be manufactured at Lupin’s facility located in Pithampur, India. This development signifies Lupin’s commitment to expanding its portfolio in the global healthcare sector.

Targeting Cholesterol Management

Pitavastatin Tablets are indicated as an adjunct to diet for reducing low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia, as well as in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). This approval positions Lupin to address a significant health concern prevalent in the U.S. and globally.

Market Potential for Lupin’s Generic Product

According to IQVIA MAT September 2023 data, Pitavastatin Tablets (Reference Listed Drug: Livalo) had estimated annual sales of USD 298 million in the U.S. market. Lupin’s entry into this segment with its generic version offers a cost-effective alternative for patients and healthcare providers, potentially capturing a substantial share of the market.

Lupin’s Strategic Move in the Pharma Sector

This FDA approval is a crucial step for Lupin in the pharmaceutical industry, aligning with its strategy to introduce competitive generic drugs in lucrative markets. The approval for Pitavastatin Tablets not only reinforces Lupin’s presence in the U.S. healthcare market but also underscores its commitment to providing accessible healthcare solutions.