The FDA has approved Teva Pharmaceutical’s generic version of Gilead’s HIV drug, Truvada, (emtricitabine/tenofovir disoproxil fumarate). The drug is used as a prophylactic in people at high risk of contracting HIV.
While the regulator acknowledged that the generic was bioequivalent to the branded drug, it’s unclear exactly when the pre-exposure prophylactic will be available on the market. According to an article on BioPharmaDIVE, the delay in the launch of the combo treatment is “likely due to ongoing patent litigation with Gilead.”
The approval letter sent to Teva confirms that they were the first generics maker to file an abbreviated new drug application (ANDA) for the HIV treatment. As such, they may be entitled to a 180-day exclusivity period during which time other generic competitors will not be able to apply to market their version of Truvada.
“We are pleased with the FDA’s decision and look forward to supporting these (HIV) patients with generic medicines when we are otherwise able to,” said Elizabeth DeLuca, associate director of global generic medicines and North America for Teva. Gilead carries a number of patents for the combination therapy which expire between 2018 and 2024.
In 2004, Truvada was originally approved as a treatment for HIV. Eight years later, the FDA approved the drug as a preventive treatment for uninfected adults at risk of contracting HIV.
While the drug hasn’t been adopted by all people who would be eligible to use it prophylactically, Gilead reported that approximately 125,000 people in the US were taking Truvada as of Q1 2017. Truvada sales in the US reached $2.4 billion in 2016, with global sales of $3.5 billion.
Gilead has faced criticism over the price of Truvada, which comes in at $1,500 per month, and some believe that this is one of the primary deterrents that is preventing more widespread use of the drug. Launch of Teva’s generic Truvada could go a long way to making this prophylactic treatment more affordable and accessible to patients.