- It takes a medication 12.8 years on average to go from a patent to store shelves. A drugmaker can expedite that time if its product treats cancer or has high potential sales. The process moves more slowly if the company acquires a treatment on its way to market rather than developing it in-house, according to findings from a QuintilesIMS report released on Monday.
- The report examined the 667 new active substances (NAS) approved in the U.S. since 1996, detailing the trends seen as a new drug goes from research to patient to the loss of patent exclusivity.
- Overall, drugs approved recently are holding onto their exclusivity for almost three years less than those in the late 1990's. Treatments that netted annual sales of more than $1 billion during their first five years on the market were an exception to this truncated exclusivity, though such blockbusters are rare.
"For manufacturers and investors alike, the prospects for biopharmaceutical innovation remain positive, even as the time elapsed from patent filing to launch remains stubbornly long and the period of exclusivity following launch is steadily declining," the report said.
While not addressed in the report, the 21st Century Cures Act, which Obama signed into law in mid-December, is likely to spur the approval of more drug development, as it could provide $4.8 billion of funding to the National Institutes of Health. Specifically, the bill provides $1.8 billion to fund cancer research specifically. As noted, oncology drugs are one of the exceptions to the general trends found in the QuintilesIMS report, making it to market on average 34 months earlier than other types of treatments, and often keeping their patent protection longer.
Treatments fetching mean yearly sales of $1 billion in their first five years on the market also retained exclusivity longer – 23 months longer, on average – "which may reflect more intense efforts by the manufacturers of those commercially successful products to maintain protection," the report said.
Few drugs ever garner those kind of returns, however. In the last two decades, only 19 have have reached that benchmark, while 62% have failed to reach $100 million in sales. Contributing to the latter group were medicines receiving orphan drug designation, which often bring in lower sales due to smaller patient populations.