How long does a patent last on a small-molecule drug?
The patent lasts for approximately 20 years from the time the invention was first made to the time that the patent expires. And the whole idea of a 20-year lifetime is that it gives the company adequate time to pay for it. The FDA also has periods of exclusivity that they award to companies if a drug gets approved. So the first time a drug gets approved, the FDA gives it an additional five years because it was the first company to get that drug approved. Look at Medicare expenditures: the highest cost is for these biotechnology products, and they cost patients tens of thousands of dollars annually. The law has to change. Are there different rules for orphan drugs? Orphan drugs, if biologics, are all subject to the same patents. Because there is no pathway to allow these drugs to be genericized, they do have the same monopoly potential. They also have market exclusivity for seven years post-approval that is awarded by the FDA. Again, that’s an incentive to bring companies to the table t
