BackAurobindo Pharma gets FDA not to launch heart-burn pill generic Nexium in US
The launch of this product is based on the settlement terms/litigation outcome with AstraZeneca Plc
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Hyderabad: Aurobindo Pharma Ltd. on Friday said it got final approval from the US Food and Drug Administration (FDA) to manufacture and market heart burn pill esomeprazole magnesium delayed-release capsules of 20 and 40 mg dosages.
The drug is a generic version of British drug maker AstraZeneca Plc.’s Nexium.
The launch of this product is based on the settlement terms/litigation outcome with AstraZeneca, Aurobindo said in a statement.
Both branded and generic Nexium had an estimated market size of $4.2 billion for the 12 months ending February according to US-based healthcare information provider IMS Health.
Aurobindo will be competing in a highly fragmented market—with five generic drug makers including Dr.Reddy’s Laboratories Ltd., Hetro Labs Pvt. Ltd., Torrent Pharmaceuticals Ltd, Teva Pharmaceutical Industries Ltd and Mylan NV along with innovator AstraZeneca.
Shares of Aurobindo gained 1.60% to close at ₹ 779.95 each on the BSE, on Friday, while the benchmark Sensex dropped 0.16% to close at 25,838.14 points.
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