New Delhi: Natco Pharma has received an approval from the Drugs Controller General of India (DCGI) to launch generic version of Gilead Sciences’ hepatitis C treatment drug in India.
“The company has received an approval for the generic version of Ledipasvir + Sofosbuvir combination from Drugs Controller General (India)”, Natco Pharma said in a BSE filing on Tuesday.
Natco Pharma plans to launch this combination drug immediately under its brand name Hepcinat LP and through its strategic partners in India, it said.
Ledipasvir+Sofosbuvir is a two-drug fixed-dose combination product that contains 90 mg of Ledipasvir and 400 mg of Sofosbuvir in a single tablet, and sold globally by Gilead Sciences Inc under its brand Harvoni.
It is indicated for the treatment of Chronic Hepatitis C (CHC) genotype one infection in adults.
“This single-tablet regimen is the first of its kind to offer significantly higher cure rates in Genotype-1 CHC infection compared to conventional therapies”, the company added.
Natco will price Hepcinat LP at a Maximum Retail Price (MRP) of Rs 25,000 for a bottle of 28 tablets. In March this year, Natco Pharma launched the generic version of Sofosbuvir in Nepal.
The firm has signed a non-exclusive licensing agreement with Gilead Sciences to manufacture and sell generic versions of its chronic hepatitis C medicines.
The agreement with Gilead allows Natco to expand access to these chronic hepatitis C medicines in 91 developing countries.
Under the license, Natco can set its own price for its generic products, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities.
At 1531 hours, the shares of Natco Pharma were trading down 0.57% or Rs 3.15 at Rs 546.10 per share intraday on BSE.