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

India Infoline News Service | Mumbai | May 18, 2018 10:04 IST

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

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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