Teva Pharmaceutical Industries Ltd. has won FDA approval for the first generic version of Gilead Sciences Inc.'s Truvada (emtricitabine/tenofovir disoproxil fumarate) a treatment for HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis.
The drug contributed nearly $3.6 billion to Gilead's 2016 revenue. A consensus forecasts for the years ahead suggests that by 2020, Gilead could see its Truvada sales fall by more than half to about $1.5 billion. Meanwhile, the company continues to be the subject of significant scrutiny from investors and analysts looking for a turnaround in 2017, signs of which have been scarce. Nonetheless, revenue lost to competition for Truvada and related medicines will be replaced in part by continued uptake of tenofovir alafenamide (TAF)-based products, especially the once-daily single-tablet Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg), launched in 2015. (See BioWorld Today, May 3, 2017.)
Teva, America's biggest generic drugmaker by revenue, first submitted an abbreviated new drug application (ANDA) to market a generic version of Truvada in the U.S. in November 2008. Not long after, Foster City, Calif.-based Gilead filed for infringement of patents that it had previously said would protect the drug until 2021. Gilead filed a second lawsuit against Teva in May 2009, leading Jerusalem-based Teva to amend its ANDA to challenge four patents relating to Viread (tenofovir disoproxil fumarate), one component of the Truvada combo, and two additional patents covering Emtriva (emtricitabine).
In February 2013, Gilead and Teva settled the litigation with an agreement that allowed Teva to launch its generic Viread product in December of this year. A separate agreement arrived in April 2014, settling ongoing Emtriva patent litigation, though the terms of the settlement were kept confidential. Other than confirming the approval of its generic Truvada, a spokeswoman for Teva declined to answer any of BioWorld's questions, leaving details about the timing of the generic's availability and potential pricing unknown.
Other drugmakers that have sought to copy Truvada include India's Strides Arcolab Ltd., Lupin Ltd., Aurobindo Pharma, Mylan NV, Aspen Pharmacare, and Apotex Inc.
Gilead granted Indian manufacturers rights to manufacture and sell generic versions of Truvada in 95 developing countries, including India in July 2011, a time at which it also granted the Medicines Patent Pool a non-exclusive license to identify generics manufacturers and grant sub-licenses for the drug in developing countries. It has also been active in broadening access to Truvada through its Gilead Access Program.