In a report titled Trends in Drug Shortages and ANDA Approvals in the U.S. (here) released by IQVIA on July 10th, IQVIA shines a light on the actual launch of generic drug products. The report indicates that “[b]etween 2013 and Q1 2024, 37% of approved generics had not launched, and it often takes over four years for 70% of generics to reach the market.” This obviously can contribute to drug shortages, which IQVIA’s research demonstrates as the report points out:
“For drugs currently on the shortages list, 62% have approved generics, yet 84% of these have at least one unlaunched product, and 21% have no generics launched at all.”
While changing economic conditions related to certain drugs may delay or even cause firms not to launch particular approved products, just think of all of the work that the FDA must expend in lengthy approval processes for products that may never see the light of day. Some ANDAs for generic drugs take three to four years or more to obtain approval. The market for the products over that period of time may have dried up due to other, more favored therapies or pricing pressures on the generic products at the time of approval may make the products no longer profitable to market.
The IQVIA study sheds light on how pricing pressure contributes to market exit for some manufacturers and provides various data charts to support its contentions. One such chart, reproduced below, depicts the number of ANDAs approved versus those launched over time.
Please read through the report and let us know what you think!
