USFDA approval to Dr Reddy’s for Esomeprazole Magnesium and to Aurobindo for Lamivudine, Tenofovir Disoproxil Fumarate

Esomeprazole Magnesium is generic equivalent to Nexium while amivudine, Tenofovir Disoproxil Fumarate is generic equivalent to Cimduo.

May 18, 2018 04:05 IST India Infoline News Service

Dr. Reddy’s has received final approval for Esomeprazole Magnesium. This is a generic equivalent of Astrazeneca Pharma’ Nexium 20mg. The drug has already become generic and has about 9 generic competitors apart from Astrazeneca. The 20 generic Nexium had sales of about ~$120mn in 2017 and we believe that Dr. Reddy’s would be able to make $3-5mn from this drug.

Aurobindo has received approval for a combination drug Lamivudine, Tenofovir Disoproxil Fumarate. Aurobindo earlier had a tentative approval for this ANDA. This combination drug is used in treatment against HIV. Mylan has launched this combination drug under the brand Cimduo, which is a similar drug to Truvada but has swapped lamivudine for emtricitabine. Truvada reported sales of $2.8bn in 2017, however, Cimduo has only recently been launched and sales date is not available at this time.

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