Gilead to Release Its U.S. Truvada Patent a Year Early to One Company

Gilead Sciences will release its patent on Truvada a year earlier than anticipated — for one company, at least.

The pharmaceutical company revealed that Teva Pharmaceuticals — the world's largest manufacturer of generic drugs, which is based in Israel — will be able to release a generic version of the HIV prevention treatment on September 30, 2020.

"Gilead reached an agreement with Teva Pharmaceuticals in 2014 to allow the early launch of a generic version of Truvada into the market in 2020, a year earlier than required," Douglas M. Brooks, Gilead's executive director for community engagement, wrote in a Wednesday email shared on Facebook by HIV activist Peter Staley, a cofounder of the PrEP4All advocacy group.

The news, first reported by Filter magazine, was buried in Gilead's new quarterly report released Wednesday. Previously, in a phone call regarding its 2017 earnings report, John Milligan, former CEO of Gilead, claimed the company would not release its patent until 2021. While this restriction still stands, Teva was granted an exception.

Truvada is the only drug that is approved for pre-exposure prophylaxis (PrEP), a treatment that, if administered daily, is at least 90 percent effective in HIV prevention, according to the Centers for Disease Control and Prevention. The drug is also used in combination with others in treatment of HIV-positive people.

The CDC itself has come under fire for not making PrEP more widely available and affordable — especially in the wake of President Trump's “Ending the HIV Epidemic” plan, which cites PrEP as a key tool in tackling the AIDS crisis.

The federal government issued $50 million in grants to researchers to develop PrEP. And despite officially holding the patent on Truvada since 2015, it has failed to reach a royalties agreement with Gilead, which has disputed the government's patent claim.

Gilead, the maker of Truvada, earned $3 billion from sales of the drug in 2018 — and none of that money went back to the taxpayer. The drug, despite being manufactured at a relatively low price, can cost a user up to $2,000 for one month's supply. While Gilead does offer patient assistance programs, the price tag can be a deterrent for those at risk for HIV, including men who have sex with men, transgender women, young people, and people of color.

More than a third of sexually active gay and bisexual men used PrEP in 2017, according to a recent report from the CDC, but usage is still "too low" among queer men of color, the federal agency's report noted. 

Aaron S. Lord, MD, a spokesperson for PrEP4All, celebrated the earlier release date of a generic Truvada as "a victory for the LGBTQ+ community, for HIV activists, and for U.S. taxpayers." But he still demanded answers from Gilead regarding its settlement with Teva and a lack of generic alternatives.

"Even their announcement today leaves Gilead with exclusive rights to Truvada as PrEP for another 15 months and Teva as the only generic manufacturer on the U.S. market," said Lord, a physician at New York University School of Medicine, in a statement. "This will do little to reduce price in a way that will increase access and PrEP4All remains suspicious of the terms and lack of transparency surrounding the Teva settlement."

"I have to ask, what’s to stop them — other than a desire for profit margins — from releasing the rights now?"

Lord also called on the CDC to reappropriate Gilead's profits to create a national HIV prevention program to help at-risk people access the medication and to offer an affordable generic form of Truvada.

Brooks, in his email, claimed the company's agreement with Teva on a generic's 2020 release was made in 2014 and "is not related to current discussions with the U.S. government to broaden access to Truvada for PrEP for vulnerable populations and support the federal plan to end the HIV epidemic. Those discussions are ongoing."

Staley, in his captioning of Brooks's email, contended that Gilead's "sweetheart deal" with Teva still prevents three other companies, Amneal, Aurobindo and Mylan, from producing a generic form of Truvada until 2021. The activist said this deal "is likely unconstitutional," and he vowed to continue placing pressure on Gilead as well as Teva in making the drug more available and affordable.

UPDATE: A previous version of this article stated that Gilead Sciences had released its patent on Truvada. The piece has been edited to clarify that only one company, Teva, is being allowed to produce a Truvada generic in 2020.