Novartis’s branded generic is called Hecoria and has been approved by FDA for the prevention of organ rejection in certain kidney and liver transplant patients.

Following organ transplantation, patients require lifelong treatment with immunosuppressants. Many transplant patients are faced with complicated post-transplant medication regimens and significant financial burden. As a branded generic, Novartis believes that Hecoria offers an option for healthcare providers who seek to have their patients receive the same brand of tacrolimus at every prescription refill, but at the affordable price of a generic drug.

Currently, there are more than 112,000 patients awaiting an organ transplant. In 2010, nearly 17,000 patients received a kidney transplant, and more than 6,000 received a liver transplant, all of whom will need lifelong treatment with immunosuppressants.

FDA approval of Hecoria was based on Sandoz’s Abbreviated New Drug Application for its generic tacrolimus, which was introduced back in August 2009, along with comparative, randomised, single-dose, 2-way crossover, bioavailability studies of Prograf and tacrolimus 5 mg capsules performed in healthy volunteers following a standard meal and under fasting conditions. Results demonstrated that tacrolimus and Prograf capsules are bioequivalent under both fed and fasting conditions.

Dr Usman Azam, Head of US Medical & Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation said that the introduction of Hecoria enabled Novartis ‘to offer the broadest portfolio of transplant immunosuppressants on the market’. He added that ‘Hecoria complements our extensive portfolio of transplant immunosuppressant medications, and underscores our ongoing commitment to delivering a broad range of treatment options to our customers and their patients.’

According to IMS Health data, annual Prograf sales in the US for the year ended April 2009 were US$929 million.

Related article

Bill introduced to ensure generics get 180-day exclusivity