After almost three months of calendar year 2022, the OGD is reporting twenty‑two first-time generic approvals. That seem like a whole lot but remember that if there are multiple first‑to‑file or first‑to‑approve ANDAs (which can sometime happen) for the same drug product, all of those that receive final approval on the same day are counted as multiple first‑time generic approvals. While this is expected as the Agency had done the work to bring the ANDAs to approval, the term “first generic approval” may seem a little skewed in the eyes of casual readers.
To make a point, of the twenty‑two first‑generic approvals thus far in 2022, eight are listed for Lacosamide tablets and three are listed for Pirfenidone capsules. Thus, one might say, hey, wait a minute, there are theoretically only first-time approvals for thirteen separate drugs. While that might be true if you look at it that way, the OGD has historically reported each separately. It must also be understood that, even though the applications may have received full approval, based on the regulatory provision for paragraph IV certifications or because of unresolved patent issues, the ANDA applicant may choose not to launch their product at risk for fear of treble damages should their patent challenge fail. Therefore, just because an ANDA has received first‑generic approval status, there is no guarantee that it will be launched in a timely manner until patent issues are either resolved, settled, or, if a firm decides to do so, an at‑risk launch is made.
Over the last six years, first‑generic approvals have ranged in number from 72 to 107 per year. Much is dependent on the universe of new products coming off patent as well as the number of sponsors seeking approval for those drugs. The listings of first‑generic approvals for the last twenty‑two years can be found here (and, remember, these are calendar‑year lists not fiscal‑year reports).
