Mylan Launches Gilead’s Sovaldi in India
Mylan N.V.’s subsidiary, Mylan Pharmaceuticals Private Limited has launched Gilead Sciences’ Sovaldi (sofosbuvir 400 mg tablets) in India. Sovaldi is indicated for the treatment of chronic hepatitis C infection, a blood-borne infectious disease, as a component of a combination antiviral treatment regimen. In February 2015, Gilead appointed Mylan as its exclusive distributor of Sovaldi in India.
Sovaldi is sold by Mylan’s dedicated sales force as part of its Hepato Care segment. Additional hepatitis C arrangements with Gilead include: a licensing and technology transfer agreement that grants Mylan the non-exclusive rights to manufacture and distribute generic sofosbuvir and generic ledipasvir/sofosbuvir and, upon FDA approval, the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816 in 91 developing countries; and an exclusivity for distribution of Gilead’s brand Harvoni (ledipasvir 90mg/sofosbuvir 400 mg tablets) in India.
Sovaldi was one of the industry's top-selling drugs in 2014 with 2014 global sales of $10.28 billion following its approval in the US in December 2013 and in the European Union in January 2014, according to Gilead's reported 2014 results, and further contributing was Harvoni, a combination therapy of sofosbuvir and ledipasvir for treating chronic hepatitis C infection, which had 2014 global sales of nearly $2.13 billion.