Mylan is launching Efavirenz Tablets USP, 600 mg, in the USA, the first generic version of Bristol-Myers Squibb’s Sustiva, which – combined with other antiretroviral agents – is used for the treatment of HIV type 1 in adults and in patients at least 3 months old and weighing at least 3.5 kg.
Mylan pointed out that more than 40% of the world’s 20 million people being treated worldwide for HIV/AIDS depend on a Mylan antiretroviral product. In the U.S., there are an estimated 1.1 million people living with HIV.
Mylan CEO Heather Bresch, said: “Our global commitment to improving access to antiretroviral medicines for this important patient population spans more than a decade, and the U.S. launch bolsters our leadership in producing high-quality ARVs and positions us to continue to lead this important category in the future.”
Referring to the FDA approval letter, Mylan notes it was one of the first applicants to submit a substantially complete ANDA for Efavirenz Tablets USP, 600 mg, containing a Paragraph IV certification, and is eligible for 180 days of generic drug exclusivity. Efavirenz Tablets USP, 600 mg, had U.S. sales of approximately $113 million for the 12 months ending December 31, 2017, according to IQVIA.
Currently, Mylan has 208 ANDAs pending FDA approval representing approximately $93.2 billion in annual brand sales, according to IQVIA. Forty-six of these pending ANDAs are potential first-to-file opportunities, representing $42.1 billion in annual brand sales, for the 12 months ending July 31, 2017, according to IQVIA.