The US Food and Drug Administration (FDA) has granted approval to two generic versions of Iron Sucrose, developed by Viatris and Amphastar. According to global brokerage firm Citi, both products could potentially qualify for 180 days of Competitive Generic Therapy (CGT) exclusivity in the US market.Citi said that while it would prefer to wait and see if additional companies secure approvals, no Indian pharmaceutical companies have announced FDA clearance for the product so far.
Among Indian generics makers, Iron Sucrose had been considered a key pipeline product for Dr. Reddy’s Laboratories and Aurobindo Pharma.
However, Citi cautioned that the latest approvals signal intensified competition, which could reduce, or even eliminate, the market opportunity for these Indian players.Iron Sucrose recorded US sales of $512 million over the past 12 months, making it a lucrative but increasingly crowded segment.
On Monday, shares of Dr Reddy’s Laboratories Ltd. ended with gains of 0.70% at ₹1,219.90. The Aurobindo Pharma stock settled 0.80% higher at ₹1,050.40.
