India – patent challenges and compulsory licensing

Even as Astellas Pharma (TYO; 4502) and Pfizer (NYSE: PFE) have received the green signal on a supplemental New Drug Application from the US Food and Drug Administration for Xtandi (enzalutamide) to treat advanced prostate cancer, the Indian patent office has denied Xtandi a patent, opening up the market to generic versions of the drug, reports The Pharma Letter’s India correspondent.

The new price in India is expected to be 70% lower than the current price for a month’s dosage, with generic competition easily driving the price to less than $0.50 per pill.

The drug costs $129,000 for a course of treatment in the USA, but just one-third of that in countries like Japan and Sweden. US net sales of Xtandi reportedly were $330.3 million for the quarter ended June 30, 2016, an increase of 11% over the comparable prior year quarter