NEW YORK — In 2012, the Food and Drug Administration approved 39 new drugs, 8 alone in December, marking the largest increase in 16 years. The wave of approvals poises pharmaceutical makers to see big gains after billions in losses in recent years to generic drug makers because of patent expirations.
2012's tally compares to a total of 30 new drug approvals in 2011 and just 21 on 2010. At least 10 of the 39 drugs received fast-track status, which enabled them to be reviewed more quickly. 2012 saw the highest number since 1996, when 53 so-called new molecule entities received approval.
The pharmaceutical sector needs a pick-up in productivity after numerous patents expired over recent years, hitting a high-point in 2012, allowing generic manufacturers to take some of the market share with low cost substitutions. The rating agency Standard & Poor estimates major U.S. drug companies have lost about $21 billion in revenue, and European businesses lost about $10 billion, in 2012 from lucrative medicines coming off patent.