Lupin gets FDA nod for Allopurinol Tablets, eyeing share in $88m market


Global pharmaceutical company Lupin Limited has announced its receipt of approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Allopurinol Tablets USP, 100 mg and 300 mg. This approval enables Lupin to market a generic equivalent to Zyloprim Tablets, 100 mg and 300 mg, of Casper Pharma, LLC. The Allopurinol tablets will be produced at Lupin’s manufacturing facility in Pithampur, India.

Allopurinol Tablets USP, available in 100 mg and 300 mg dosages, are indicated for several critical health conditions. They are used in the management of adult patients showing signs and symptoms of primary or secondary gout, including acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy. Furthermore, these tablets are prescribed for adult and pediatric patients undergoing cancer therapy which causes elevations of serum and urinary uric acid levels, and for adult patients with recurrent calcium oxalate calculi who exhibit high levels of daily uric acid excretion.

Lupin's Allopurinol Tablets Approved by FDA, Set to Compete with Zyloprim

Lupin’s Allopurinol Tablets Approved by FDA, Set to Compete with Zyloprim

The market for Allopurinol Tablets in the U.S. is significant, with the reference listed drug (RLD) Zyloprim having estimated annual sales of USD 88.1 million (IQVIA MAT October 2023). Lupin’s entry into this market with its generic version represents a strategic move to capture a share of this lucrative market segment.

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Lupin’s achievement in receiving FDA approval for its Allopurinol Tablets underscores the company’s commitment to expanding its portfolio in the generic drugs market. It also highlights the importance of Indian pharmaceutical companies in the global healthcare industry, particularly in providing affordable and accessible medication options.

This approval not only marks a milestone for Lupin Limited in the U.S. pharmaceutical market but also represents a significant development in the broader healthcare industry. It contributes to the availability of effective treatments for patients with gout, cancer-related uric acid issues, and calcium oxalate calculi, enhancing the quality of patient care and management of these conditions.

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