Gilead Sciences is relaxing its patent on Truvada, the brand name for their pre-exposure prophylaxis (PrEP) medication, allowing Teva Pharmaceuticals to release a generic version in 2020. The news appeared on page 35 of their quarterly report to the Securities and Exchange Commission, released on Wednesday.
“Pursuant to a settlement agreement relating to patents that protect Truvada and Atripla, Teva Pharmaceuticals will be able to launch generic fixed-dose combinations of emtricitabine and TDF and generic fixed-dose combinations of emtricitabine, TDF and efavirenz in the United States on September 30, 2020,” reads the filing.
PrEP, when taken daily, is 99% effective at preventing the transmission of HIV. It has also proven effective in treating HIV positive people when used in combination with other drugs.
According to the centers for Disease Control and Prevention, the drug is taken by 35% of sexually active men who have sex with men, though usage lags amongst men of color.
The move to allow a generic version of PrEP onto the market comes one year earlier than expected from Gilead. The former CEO of Gilead, Douglas M. Brooks, had said in a 2017 earnings report that they would not be releasing its patent until 2021. The TEVA deal is an exception to the above, with Gilead claiming that the agreement with Teva was made back in 2014.
Gilead had fought to keep other generic versions off the market after the Food and Drug Administration approved the applications of four companies to market generic versions of the drug.
Aaron S. Lord, MD, a spokesperson for the PrEP4All Collaboration, hailed the earlier than expected release, calling it “a victory for the LGBTQ+ community, for HIV activists, and for U.S. taxpayers.”
In recent months, activist groups such as PrEP4All have been pushing for the patent on PrEP to be broken, citing the high cost of the drug as one of the reasons it has not been more widely adopted.
Lord, however, was nevertheless skeptical of the announcement, noting that limiting the generic market to one company will do little to lower the cost of the drug. Teva Pharmaceuticals will have exclusive rights to produce the medication for 15 months beginning in September, effectively locking up the generic market through 2021.
PrEP4All also questioned statements made by Gilead, as well as calling on the CDC to “use its significant leverage to ensure that generic Truvada is available at a price affordable to everyone in this country.”