Emory licensed emtricitabine (FTC), a potent nucleoside reverse transcriptase inhibitor, to Triangle Pharmaceuticals, Inc. (an Emory start-up company) in 1996. In 1999 and again in 2002, Emory resolved patent disputes with various third parties to consolidate intellectual property rights and thereby clear the path to market for FTC. Shortly after Triangle's September 2002 NDA filing for the use of FTC to treat HIV, Triangle was acquired by Gilead Sciences (December 2002). In July 2003, Emtriva® (emtricitabine) was cleared for marketing by the FDA for the treatment of HIV in the United States and in October 2003, the European Commission granted Marketing Authorisation for Emtriva® in all member states of the European Union.
Since FTC’s approval, it has been co-formulated with other compounds active against HIV in combination products to improve efficacy and patient compliance.
- Truvada® is a combination of EMTRIVA and VIREAD, both nucleoside analog HIV-1 reverse transcriptase inhibitors. TRUVADA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. It was initially approved in 2004. In 2012, the FDA approved once-daily oral Truvada® to reduce the risk of sexually acquired HIV-1 infection in high-risk adults when used in combination with safer sex practices. Truvada® is the first agent to be approved for HIV prevention in uninfected adults.
- Atripla® is a combination of three agents: SUSTIVA® (efavirenz), EMTRIVA® (emtricitabine) and VIREAD® (tenofovir disoproxil fumarate). Atripla® was the first ever once-daily single tablet reginen for HIV intended as a stand-alone therapy or in combination with other antiretrovirals. By combining three drugs into a single, once-daily pill, Atripla® reduces pill burden and simplifies dosing schedules and therefore has the potential to increase adherence to antiretroviral therapy. The FDA approved Atripla® in July 2006. In North America and Europe, Atripla® is marketed jointly by Gilead and BMS, but in much of the developing world, marketing and distribution is handled by Merck & Co. pursuant to an agreement between Merck and Gilead in 2006. Merck announced that it will lower the cost of the drug in countries with high HIV prevalence, that it will price Atripla® on a sliding scale based on each country’s wealth and that it will during the first half of 2007 register Atripla® in 45 countries in the Middle East and Africa and in 9 countries in Latin America, the Caribbean and Asia.
- Complera® is a triple combination of HIV therapeutic agents including emtricitabine. It includes two nucleoside analog HIV-1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of HIV-1 infection in treatment-naive adults and in patients for whom Atripla is counterindicated. It was approved in August 2011 in the US.
- Stribild™ is a "quad" pill, a combination of 1 integrase strand transfer inhibitor (elvitegravir), 1 pharmacokinetic enhancer (cobicistat), and 2 nucleos(t)ide analog HIV-1 reverse transcriptase inhibitors (emtricitabine, tenofovir disoproxil fumarate), is indicated as a complete regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve. Stribild™ reduced side effects over Atripla® with equivalent efficacy. It was first approved for use in the US in August 2012.
- Genvoya®, a quad pill, contains emtricitabine, elvitegravir, cobicistat, and tenofovir alafenamide (TAF). Genvoya® is the first TAF-based regimen to receive FDA approval for the treatment of HIV-1.
- Odefsey® contains emtricitabine, rilpivirine, and tenofovir alafenamide. Upon US approval in March 2016, it was the smallest pill for any single tablet regime for the treatment of HIV.
- Descovy® contains emtricitabine and tenofovir alafenamide. The single tablet formulation has been described as a second generation version of Truvada® and minimizes the side effects associated with antiretroviral therapy. The FDA approved Descovy® in April 2016.
- Biktarvy® contains emtricitabine, bictegravir, and tenofovir alafenamide. Gilead describes the single tablet formation as a complete regimen for the treatment of HIV infection in adults. The FDA approved Biktarvy® in February 2018.