The FDA approved the first generic of Baloxavir Marboxil tablets 40 mg and 80 mg for Norwich Pharmaceuticals Inc., on June 17, 2026. It is the generic equivalent of Genentech’s Xofulza approved for:
- Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications, and
- Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.
At first blush, this seems like a big win for patients; however, a settlement agreement reached in the patent case will likely delay launch for another 14 years. While this product currently appears in the active section of the Orange Book, firms are required to notify the Office of Generic Drugs if their approved product will not be marketed within 6 months of approval. Once OGD receives notice that the approved product is not being marketed, the product listing will be moved and will then reside in the discontinued section of the Orange Book until such time as the current settlement date arrives or until there is some other action by both parties that permits an earlier entry. We will need to keep an eye on this issue, but it does seem like this Hatch-Waxman quirk, at least in this case, does not do consumers any favors, unfortunately.
