The Indian Patent Office’s decision to reject a product patent for Gilead Sciences Inc’s adefovir dipivoxil variant, a new form of its Hepatitis B drug, Hepsera, has come as a boon for Indian copy-cat drug makers such as Ranbaxy, Cipla and Sun Pharma.
While Cipla markets a generic version of this drug as Adsera, Sun Pharma markets the drug as Adfovir and Ranbaxy Laboratories as Adheb.
Adefovir is a new-generation drug to treat Hepatitis B, a chronic disease in which liver swells due to a virus infection. Bristol-Myers Squibb’s Baraclude (entecavir), GlaxoSmithKline’s Hepitec (lamivudine) and its copycat, Lamivir-HBV by Cipla, are commonly prescribed drugs for Hepatitis B. Adefovir is considered to have lesser side effects than the other two drugs, according to industry sources.
According to Decision Resources, a research and advisory firm focusing on pharmaceutical and healthcare issues, the Indian Hepatitis B virus drug market will touch Rs 83 crore by 2012.
The Delhi patent office rejected the patent protection for Gilead Sciences Inc’s crystalline form of adefovir dipivoxil a month ago based on a pre-grant opposition filed in September 2005 by Ranbaxy Laboratories. Ranbaxy challenged the application saying the patent application was for a new form of a known substance.