Gilead informed of approval request from Teva

Gilead Sciences has been informed Teva Pharmaceutical Industries is seeking approval from the US Food and Drug Administration (FDA) to sell a generic version of Truvada.

As a result, Gilead said it has 45 days following receipt of the notification by the FDA, in order to begin a patent infringement lawsuit against Teva.

The company adds Teva has claimed two of the patents associated with one of the product’s contributing drugs, which is owned by Emory University.

Such an action would restrict the agency’s approval for either up to 30 months, or until a court rules in favour of Teva.

Truvada, used in the treatment of HIV, is a combination of Viread (tenofovir) and Emtriva (emtricitabine) – both manufactured by Gilead.

Gilead has said the product is protected by ten patents, with all of them requiring invalidation or expiration before a generic version of Truvada could be marketed.

The news comes as the company has announced two-year data from phase III studies, which have been evaluating Viread for the treatment of chronic hepatitis B virus (HBV).

Results from the research found patients who received Viread for up to 96 weeks experienced sustained suppression of HBV levels in the blood.