Natco gets DCGI approval to launch generic hepatitis-C drug Harvoni in India
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Hyderabad: Natco Pharma Ltd on Tuesday said the government has allowed it to launch the generic version of US-based Gilead Sciences Inc.’s hepatitis-C drug Harvoni in India.
Natco is the second Indian drug maker to get Drug Controller General of India (DCGI) approval for generic Harvoni in India. Last week, the India drug regulator approved Hetero Drugs Ltd’s copycat version of Harvoni.
Harvoni, the fixed-dose combination of ledipasvir-sofosbuvir of 90mg and 400mg, respectively, is an improved version of Gilead’s hepatitis-C drug Sovaldi or sofosbuvir.
Natco will market generic Harvoni under the brand name Hepcinat LP in India.
“Natco plans to launch this combination drug immediately, under its brand name Hepcinat LP, and through its strategic partners in India,” the company said in a statement.
Natco said it will price its generic at Rs.25,000 for a bottle of 28 tablets.
Harvoni, approved by US Food and Drug Administration (USFDA) for the treatment of chronic hepatitis-C genotype-1 infection, was shown to have high cure rates of around 90%.
Harvoni costs $1,350 per day in the US for a 12-week regimen.
Natco entered into a non-exclusive licensing agreement with Gilead Sciences early this year to manufacture and market chronic hepatitis-C medicines, including Sovaldi and Harvoni for India and 100 other developing countries by paying 7% royalty on sales.
Gilead signed similar non-licensing agreements with 10 other large generic drug makers—including Hetero Drugs Ltd, Cadila Healthcare Ltd, Cipla Ltd, Mylan Laboratories Ltd, Ranbaxy Laboratories Ltd (now owned by Sun Pharmaceutical Industries Ltd), Sequent Scientific Ltd and Strides Arcolab Ltd––to sell cheaper versions of Solvadi and Harvoni in 101 developing countries having an average per capita income of less than $1,900 and account for about 54% of those with hepatitis-C.
In October, Natco Pharma launched generic Harvoni in Nepal, at Rs.25,000 for a bottle of 28 tablets.
In January, the Indian patent office rejected an application filed by Gilead for Sovaldi and its follow-on hepatitis-C treatments after Natco and US-based non-profit organisation, the Initiative for Medicines, Access & Knowledge, challenged Gilead patents on grounds of the drug’s non-novelty.
Sovaldi costs $1,000 a day in the US for a 12-week regimen.
Hepatitis-C is a growing public health concern, particularly in developing countries. In India alone, it is estimated that 12-18 million patients are infected with Hepatitis-C. If left untreated, chronic hepatitis-C increases the risk of liver failure, cirrhosis of liver and hepatocellular carcinoma.
Shares of Natco dropped 0.46% and were trading at Rs.546.70 at 12.25pm on BSE, while the benchmark Sensex index declined 0.02% to 25,156.36 points.