Currently, drug companies can use piggybacking of patents to obtain seven years of market exclusivity for new drugs even when they are economically viable without this patent protection. Maintaining exclusivity can allow drug companies to make billions in profit without market competition.
In 2019, it was revealed that the manufacturer of buprenorphine, a drug that is critical to medication-assisted treatment (MAT) for opioid use disorder, was attempting to use the orphan drug approval process to secure an additional seven years of exclusivity and block potentially cheaper generic versions of the medication from reaching the market. In response to this, Sen. Shaheen wrote a letter to the Food and Drug Administration (FDA) calling on it to prevent buprenorphine’s manufacturer from abusing the system in this way. This, along with public uproar, led to the FDA revoking buprenorphine’s orphan drug status.
There are currently no drugs that have orphan drug exclusivity under the cost recovery pathway.