Sanofi Gains OTC Rights in US to Roche’s Flu Drug Tamiflu
Sanofi has signed an agreement with Roche for the exclusive over-the-counter (OTC) rights in the US to Roche’s Tamiflu (oseltamivir phosphate) for the prevention and treatment of influenza. Tamiflu is currently sold in the United States by Roche’s Genentech for prescription use.
Under the agreement, Sanofi will be responsible for leading FDA negotiations for the OTC switch and subsequent exclusive marketing, scientific engagement and distribution of Tamiflu OTC in the US.
In addition to leading the FDA negotiations, Sanofi will also be responsible for leading the clinical program and funding all studies needed to support the OTC switch in the US in consultation with experts in the field. Roche will continue to market Tamiflu in the rest of the world. Sanofi will retain the rights to first negotiations for switch rights in other selected markets, according to Sanofi.