Generic PrEP is coming — but not just yet.
Gilead Sciences announced on May 8 that it would release its patent on Truvada for PrEP next year, but many advocates are holding short of celebrating because they say the need for generic HIV prevention medication is too immediate to wait any longer.
On page 35 of an Securities and Exchange Commission quarterly filing, Gilead stated that “[p]ursuant to a settlement agreement,” it would remove the patent on emtricitabine and tenofovir, which are two ingredients in PrEP. The company also indicated that Teva Pharmaceuticals would be the one company allowed to launch generic PrEP.
Gilead did not immediately respond to a request for comment in the hours following the disclosure.
The development, nonetheless, represented a major shift after Gilead became engulfed in widespread criticism during the growing movement led by the PrEP4AllNow Collaboration and other activists who have demanded a generic version of PrEP. The pharma giant has been blasted not only for ripping off consumers by charging a price far higher than in many other nations, but for raking in immense profits even though the US government technically owns the patent, having funded scientific advancements that benefited the company.
The move also came shortly after government forces started to mount pressure on Gilead. Advocates found that the company had made more than $3 billion on PrEP, prompting seven US senators to write a letter last month to Health and Human Services Secretary Alex Azar seeking more information about government patents on the medication. And the Washington Post reported in April that the Justice Department is looking into whether Gilead ran afoul of the government patent.
Dr. Aaron S. Lord said in a written statement via Break
“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 US market,” Lord said. “This will do little to reduce the 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?”