- Gilead has been working with India's health ministry to find a workable solution to the problem of distributing Sovaldi (sofosbuvir) at an accessible price in India, while still protecting the integrity of its patents. A solution may be in the works.
- Currently, Gilead and the Indian government are targeting June 2015 as the date when generic sofosbuvir will be available in India under an expanded generic licensing agreement with Indian drugmakers. The agreement also includes launching an investigational combination pill that combines sofosbuvir and another agent.
- Based on the agreement, Sovaldi will be available in India for $900 for a 12-week regimen.
The Sovaldi situation in India has virtually required around-the-clock monitoring. For example, on January 13, when Indian regulators approved Sovaldi, the Indian patent office rejected Gilead's patent claims covering the active metabolite of sofosbuvir. Not only has Gilead licensed eight India-based generic manufacturers to develop and distribute cheaper versions of Sovaldi to 91 mainly low-income countries, but it is moving forward to development of the combo pill for hepatitis C that combines sofosbuvir with GS-5816, which, if approved, could treat six genotypes of hepatitis C. At the root of this challenging situation is the high demand for an effective, user-friendly treatment option for hepatitis C---which is a major problem in many developing countries. Nonetheless, all companies have the right to attempt to enforce their patent rights. Gilead and India are actively looking for a workable solution.