Lupin gets USFDA nod for generic HIV drug

The Mumbai-based company said it is the exclusive first filer for 800 mg tablets and is eligible for 180-day exclusivity.

Lupin: Lupin receives US FDA nod for Mirabegron tablets. The pharma company has received approval from the United States Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA), Mirabegron extended-release tablets, to market in the US. Mirabegron is a generic equivalent of Myrbetriq extended-release tablets of Astellas Pharma Global Development, Inc. The product will be manufactured at Lupin’s facility in Nagpur, India. The drug had estimated annual sales of $ 2403 million in the US as per IQVIA MAT data by June 2022. The drug is used for treatment of certain bladder problem.

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//$ (‘#mcpcp_addportfolio .form_field input, .form_field select, .form_btn input’).attr(‘disabled’, false); // //if(call_pg == “2”) //{ // adtxt =’ Scheme added to your portfolio We recommend you add transactional details to evaluate your investment better. x‘; //} //else //{ // adtxt =’ Stock added to your portfolio We recommend you add transactional details to evaluate your investment better. x‘; //} //$ (‘#mcpcp_addprof_info’).css(‘background-color’,’#eeffc8′); //$ (‘#mcpcp_addprof_info’).html(adtxt); //$ (‘#mcpcp_addprof_info’).show(); glbbid=v.id; } }); } }); } else { AFTERLOGINCALLBACK = ‘pcSavePort(‘+param+’, ‘+call_pg+’, ‘+dispId+’)’; commonPopRHS(); /*work_div = 1; typparam = t; typparam1 = n; check_login_pop(1)*/ } } function commonPopRHS(e) { /*var t = ($ (window).height() – $ (“#” + e).height()) / 2 + $ (window).scrollTop(); var n = ($ (window).width() – $ (“#” + e).width()) / 2 + $ (window).scrollLeft(); $ (“#” + e).css({ position: “absolute”, top: t, left: n }); $ (“#lightbox_cb,#” + e).fadeIn(300); 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}else{ stk_str+=’,’+stkData.stockId.trim(); } }); $ .get(‘//www.moneycontrol.com/techmvc/mc_apis/stock_details/?sc_id=’+stk_str, function(data) { stk.forEach(function (stkData,index){ $ (‘#stock-name-‘+stkData.stockId.trim()+’-‘+article_id).text(data[stkData.stockId.trim()][‘nse’][‘shortname’]); }); }); function redirectToTradeOpenDematAccountOnline(){ if (stock_isinid && stock_tradeType) { window.open(`https://www.moneycontrol.com/open-demat-account-online?classic=true&script_id=$ {stock_isinid}&ex=$ {stock_tradeType}&site=web&asset_class=stock&utm_source=moneycontrol&utm_medium=articlepage&utm_campaign=tradenow&utm_content=webbutton`, ‘_blank’); } }

Drug firm Lupin on Tuesday said it has received an approval from the US health regulator to market Darunavir Tablets, used to treat Human Immunodeficiency Virus (HIV) infection, in the American market.

The Mumbai-based company said it is the exclusive first filer for 800 mg tablets and is eligible for 180-day exclusivity.

Lupin will also potentially have shared 180-day exclusivity on the 600 mg tablets, it added. The company has received the approval from the US Food and Drug Administration (USFDA) for the medication in strengths of 600 mg and 800 mg, Lupin said.

The drug firm’s product is a generic equivalent of Janssen Products’ Prezista Tablets. As per MAT June 2022 data, Darunavir tablets (600 mg and 800 mg) had estimated annual sales of USD 343 million in the US.

Lupin shares were trading 2.17 percent up at Rs 738.30 apiece on the BSE.