Viswanath Pilla Moneycontrol News
Aurobindo Pharma, India's fourth largest drugmaker, on Monday said it had received final approval from the US drug regulator to launch cold and cough over-the-counter (OTC) drug Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets of 600/30 mg and 1200/60mg.
Aurobindo’s Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets are the generic equivalent of Reckitt Benckiser’s Mucinex tablets.
The product will be launched in the first quarter of the next financial year, Aurobindo said in a statement after market hours on Monday.
Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets help loosen mucus and phlegm, and thin out bronchial secretions, thus easing symptoms.
The approved product has an estimated market size of USD 235 million for the 12 months ending December 2016, according to an IRI database.
Last week, Aurobindo won a patent-infringement case brought against it by US-headquartered Reckitt Benckiser in a district court in the state of Delaware to block the launch of generic Mucinex in US.
Aurobindo had filed an Abbreviated New Drug Application (ANDA) in 2014 to market a generic version of Mucinex tablets, one of the most popular cough and cold treatments in the US.
This is the 106th ANDA (including 21 tentative approvals) approved from the Unit VII formulation facility in Hyderabad used for manufacturing oral products.
Aurobindo now has a total of 311 ANDA approvals.
Shares of Aurobindo rose 2.38 percent to close at Rs.703.20 on BSE.
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