In Argentina INPI rejected a key patent on Sofosbuvir

Argentina has made an important step forward to protect  local production of generics of an essential medicine to treat Hepatitis C. This brings significant advantages for Public Programs which procure the medicines. Buenos Aires, December 4, 2017. In Argentina, the INPI (National Institute of Industrial Property) rejected GILEAD PHARMASSET LLC patent application on Sofosbuvir prodrug, an essential medicine to treat HepC. The resolution PN 066898 of INPI

The Week in Review: July 28 – August 4, 2017

Friday, August 4, 2017 Treatment: This last week saw the approval in the U.S. of AbbVie’s Mavyret, a pangenotypic also indicated as recuperation therapy for those with GT1 who have failed treatment with DAAs. U.S.: FDA approves Mavyret for Hepatitis C As well, the FDA has approved updated labeling for Epclusa to include use in patients co-infected with HIV. U.S. FDA Approves Expanded Labeling for Epclusa® (Sofosbuvir/Velpatasvir) for the Treatmen...

WHO approves generic drug to treat hepatitis C

The World Health Organization has approved the first generic version of sofosbuvir, a critical drug in the treatment of hepatitis C. This development could expand access to treatment by increasing the number of quality-assured generic medicines in the market. Sofosbuvir, a 400mg tablet, is manufactured by Mylan Laboratories Ltd India. “This is a breakthrough medicine with a 95-per cent cure,” Suzanne Hill, director of essential m...

WHO prequalifies first generic active ingredient for hepatitis C medicines

On 31 March 2017, WHO for the first time prequalified a generic active pharmaceutical ingredient (API) for hepatitis C – sofosbuvir. Sofosbuvir is an essential ingredient for new, highly effective medicines to treat hepatitis C called direct active antivirals (DAAs). The prequalified product’s manufacturer is Mylan Laboratories Ltd - INDIA. The emergence of DAAs in 2014 gave new hope to the 80-110 million people suffering from chronic hepatitis C, a disea