BMS Resolves US Patent Litigation for Sustiva

Bristol-Myers Squibb reports that it has successfully resolved all outstanding US patent litigation relating to efavirenz, an active ingredient contained in Sustiva (efavirenz) and Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) products. Accordingly, the company says it believes that loss of exclusivity in the US for efavirenz should not occur until December 2017.

The Sustiva franchise includes the company’s Sustiva, a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV, and bulk efavirenz, which is also included in the combination therapy, Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir and disoproxil fumarate 300 mg), a product sold through the company’s alliance with Gilead Sciences. In 2013, the Sustiva franchise posted sales of $1.6 billion.

Earlier this year, Bristol-Myers Squibb submitted a new drug application to the US Food and Drug Administration for a fixed-dose combination of atazanavir sulfate and cobicistat, an investigational pharmacokinetic enhancer. In addition, studies are ongoing for new treatments, including an HIV-1 attachment inhibitor (BMS-663068), an HIV-1 maturation inhibitor (BMS-955176), and an anti-PD-L1 (BMS-936559).

Source: Bristol-Myers Squibb


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