HYDERABAD: Two city-based drug makers Natco Pharma and Hetero said they received approval from the Drugs Controller General of India (DCGI) to sell generic version of Daclatasvir, used for the treatment of chronic hepatitis C.
“It is the first company in India to get approval for generic Daclatasvir Dihydrochloride (Daclatasvir) tablets, 30 mg & 60 mg, from the Drugs Controller General (India),” Natco said in a disclosure with the bourses.
Daclatasvir is the first-in-class NS5A inhibitor used in combination with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection.
“The company has received the approval from Drug Controller General of India for the generic version of Daclatasvir tablets in the strengths of 30 mg and 60 mg,” Hetero said.
Natco said it will launch immediately in India at `6,000 and `4,000 for the 60 mg and 30 mg strengths, respectively, for a bottle of 28 tablets.
“Compared with other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV patients subsets,” Natco said adding that it will market generic Daclatasvir under its own brand ‘NATDAC,’ and through its strategic partners in India.
Hetero said its product was a generic version of Bristol-Myers Squibb’s Daklinza tablets. It has over 25 manufacturing facilities worldwide and its portfolio includes over 200 products in therapeutic categories like HIV/AIDS, cardiovascular, oncology, neurology and hepatitis.
Meanwhile, Natco said and its partner Alvogen settled a patent infringement suit with Gilead Sciences Inc and others over Tamiflu in a US court.