The Indian Patent Office recently denied a patent for the drug Xtandi (Enzalutamide) by Japanese firm Astellas Pharma used in treatment of prostate cancer. This decision comes in the light of the pre-grant opposition filed by pharma companies BDR Pharma, drug company Fresenius Kabi and Indian Pharmaceutical Alliance. This decision will pave the way for generic competition in India and bring the price down drastically. At present, the drug is sold Rs 3.35 lakh for a pack of 112 capsules for a month’s dose which is expected to go down by 60-70% on the entry of generics in the market.
See the news report here:
In US, several civil society organisations have submitted a petition in beginning of this year to the National Institutes of Health (NIH) relating to this drug asking to exercise its authority under the Bayh-Dole Act to authorize the generic production.
Enzalutamide, marketed as Xtandi by the J, was developed with the support of NIH and DoD grants at the University of California, Los Angeles. Astellas markets Xtandi for over $129,000 per year per patient in the United States. The petition and press release can be read here and here.