Mylan first to launch generic Sustiva
Mylan has launched its generic of Bristol-Myers Squibb’s Sustiva (efavirenz) tablets. Mylan’s generic Sustiva is the first copycat of the drug, which is indicated to treat HIV-1 alongside other antiretroviral agents in adults and children at least 3 months old 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,” 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.”
The Food and Drug Administration noted in its approval of Mylan’s generic Sustiva that it is eligible for 180 days of market exclusivity, as it was one of the first substantially complete generics submissions for the product.
Mylan’s generic will be available in 600-mg dosage strength tablets. The product had U.S. sales of roughly $113 million for the 12 months ended Dec. 31, 2017, according to IQVIA data. Roughly 1.1 million patients in America live with HIV.
“With the launch of efavirenz, Mylan marks an important achievement in bringing more affordable treatment options to the HIV patient community,” 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.”
The Food and Drug Administration noted in its approval of Mylan’s generic Sustiva that it is eligible for 180 days of market exclusivity, as it was one of the first substantially complete generics submissions for the product.
Mylan’s generic will be available in 600-mg dosage strength tablets. The product had U.S. sales of roughly $113 million for the 12 months ended Dec. 31, 2017, according to IQVIA data. Roughly 1.1 million patients in America live with HIV.