Back in August 2023, we reported the approval of a significant number of Lisdexamfetamine ANDAs (here) that we believed would mitigate the ongoing shortage. Today, however, the FDA reported (here) that Lisdexamfetamine capsule dosage-form products are in trouble again. On the list of Lisdexamfetamine Dimesylate Capsule drug shortages are eleven companies, with only two of them reporting availability in all product strengths. Nine of the firms report various levels of limited availability or that the product is on allocation, they have no active ingredient available, that some product will be available in February 2024, or that the product is currently totally unavailable.
When we first reported on this issue, we made note that we were uncertain as to how the market would respond to the long list of new approvals and how these would impact the previous critical shortages. Well, it appears that those approvals may have been a short-term fix as the pent-up demand likely gobbled up most of the released and back-up inventory after the August ANDA approvals, and firms are still having difficulty keeping up with the demand. This is renewed bad news for patients that rely on this product for their treatment.
The continued pressure on this market, the DEA, and the manufacturers is certainly going to ramp up quickly if the supply continues its apparent downward cycle. There are reports of patients hoarding drugs in this shortage situation, which makes the problem even worse. We will need to see what happens in the coming months.
