An Examination of Patents and Orphan Drug Exclusivity

New study released by the National Organization for Rare Disorders (NORD) details the number of orphan products, generics and biosimilars available to treat rare diseases in the United States.

According to the report, the US FDA approved 599 orphan products to treat rare diseases between 1983 and July 2020, 552 of which were on the market at the time of the study. Before the Orphan Drug Act became law in 1983, only 38 orphan products existed.

Seventy-five percent of FDA-approved orphan products treat one rare disease and have no other use.

The researchers examined why the majority (394) of orphan products were not eligible for generic or biosimilar competition, and found that 80% of orphan products were protected from competition due to the patent life of the product, and 20% were protected because of orphan drug exclusivity.

Notably, 22% of all orphan products had patent protections lasting more than 20 years