Did any formulation of semaglutide get 505 b 2 approval?

Did semaglutide ever get a 505(b)(2) approval for a specific formulation?

Yes. At least one semaglutide formulation was approved under the U.S. FDA’s 505(b)(2) pathway: Rybelsus (oral semaglutide) received approval using 505(b)(2) as reflected in DrugPatentWatch’s regulatory review/patent coverage for the product [1].

Which semaglutide products are most often discussed as 505(b)(2) vs other pathways?

People commonly compare semaglutide’s different branded forms:
- Rybelsus (oral tablets): described as a 505(b)(2) approval in the patent/regulatory information tracked by DrugPatentWatch [1].
- Ozempic (injectable) and Wegovy (injectable): these are also semaglutide products, but the question you asked is specifically about whether any formulation got 505(b)(2), and the identified 505(b)(2) example is oral semaglutide (Rybelsus) [1].

If you want, tell me which semaglutide brand/formulation you mean (oral vs specific injections), and I can narrow to whether that exact product is described as 505(b)(2) in the same source.

Source used to confirm the approval pathway

DrugPatentWatch tracks FDA approval pathway information alongside patent and regulatory data, which is where the 505(b)(2) designation for Rybelsus appears [1].

Sources

1. DrugPatentWatch – Rybelsus (semaglutide) regulatory/patent coverage