Mylan Pharmaceuticals has launched generic Harvoni® (Ledipasvir 90 mg/Sofosbuvir 400 mg) tablets under the brand name MyHep LVIR™ in India.
There are approximately 12 million people who are chronically infected with Hepatitis C in India and most do not know they are infected.1 The Ledipasvir/Sofosbuvir combination is indicated for the treatment of Hepatitis C infection and offers a simplified Hepatitis C treatment regimen that eliminates the need for interferon and ribavirin. The product also is a single-tablet regimen and requires a therapy course of just 12 weeks. Harvoni® has exhibited high cure rates and a tolerable side effect profile across a range of patient populations.
Mylan President Rajiv Malik said, "Mylan recognizes the urgent need to expand access to high quality, affordable Hepatitis C treatment options in India, where roughly 12 million people are infected with the virus. MyHep LVIR™ is an important addition to our growing Hepato Care segment in India that gives us the opportunity to offer patients the potential to be cured through a transformative and simplified single tablet, once-daily treatment regimen. Moreover, consistent with our commitment to create better health for a better world, we are introducing various educational initiatives in India to raise awareness of the disease and its treatment options."
The launch of MyHep LVIR™ follows the successful launch of generic Sofosbuvir in India under the brand name MyHep™ in April 2015. In September 2014, Mylan entered into a licensing and technology transfer agreement with Gilead granting Mylan the non-exclusive rights to manufacture and distribute generic Sofosbuvir and Ledipasvir/Sofosbuvir tablets in 101 developing countries, including India.
Mylan also entered into an agreement with Gilead in February 2015 as the exclusive distributor of Gilead's branded Sovaldi® (Sofosbuvir 400 mg) and Harvoni® tablets in India. Mylan launched Sovaldi® in India in May 2015.