HERTFORDSHIRE, England, and PITTSBURGH: Mylan NV announced the US launch of Efavirenz Tablets USP, 600 mg, the first generic version of Bristol-Myers Squibb’s Sustiva®.
The product is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.
“With the launch of Efavirenz, Mylan marks an important achievement in bringing more affordable treatment options to the HIV patient community,” said Mylan CEO Heather Bresch. “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.”
According to the FDA approval letter, Mylan 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 Dec. 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.