Gilead to launch generic Sovaldi in India this summer

Source: BioPharma Dive

29 Jan 2015

Dive Brief:

  • Gilead has been working with India’s health ministry to find a workable solution to the problem of distributingSovaldi (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.

Dive Insight:

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.

This entry was posted in Generics, Hepatitis C, Sofosbuvir. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s