BRIEF—Patent exclusivity of Truvada for PrEP questioned

Analysis of the US Food and Drug Administration’s Orange Books, which among other information list drug patents as provided by pharmaceutical groups, shows no exclusivity for Gilead Sciences’ Truvada (emtricitabine/tenofovir) for preventive use, a treatment known as pre-exposure prophylaxis, or PrEP.

PrEP is 99% effective in preventing HIV infection, the Financial Times reported today.

The FDA approved Truvada for therapeutic and preventive use in 2004 and 2012, respectively.

“Truvada was not granted any exclusivity specific to PrEP by the FDA that was in effect between 2012 and now. That absence of exclusivity meant and means one fewer obstacle for generics to come into the market,” said Christopher Morten, a staff attorney and lecturer at Yale Law School.

Gilead dismissed this, however, saying: “The patents listed in the Orange Book for Truvada cover all uses of the product, including for treatment for HIV [and two types of prophylaxis, including PrEP]. We did not obtain new patents related to the PrEP indication,” according to the FT article.

https://www.ft.com/content/c1bf5cb6-b868-11e9-96bd-8e884d3ea203