Novo Nordisk Rebrands Rybelsus as Oral Ozempic, Sues Hims & Hers Over Compounded Semaglutide

On February 4, 2026, Novo Nordisk announced that oral semaglutide previously marketed as Rybelsus will be rebranded as oral Ozempic, with availability expected in the US in Q2 2026. The FDA approved 14 mg oral semaglutide now branded as Ozempic for type 2 diabetes.

The development does not represent a new molecular entity, but rather a reformulation and strategic rebranding of oral semaglutide previously marketed as Rybelsus. Based on bioequivalence data, the updated formulation maintains comparable efficacy, safety, and pharmacokinetic properties to earlier oral semaglutide doses, while offering a more concentrated preparation that simplifies dosing without altering potency.

The rebranding aligns oral and injectable products under consistent brand identities tied to indication. Historically, clinicians navigated distinct brand identities—Wegovy for weight management and Ozempic for type 2 diabetes—across injectable formulations, while oral semaglutide carried a separate name. This fragmentation often created confusion for patients and added complexity to prior authorizations, particularly given the substantial overlap between type 2 diabetes and obesity in clinical populations. By aligning oral and injectable products under consistent brand identities tied to indication, prescribing discussions become clearer and more intuitive for both clinicians and patients.

Name recognition appears to significantly influence patient interest and engagement. While oral semaglutide was previously available, uptake of Rybelsus was perceived as modest. In contrast, rebranding to oral Ozempic—and the introduction of oral Wegovy—has already generated increased patient inquiries, suggesting that familiarity with established GLP-1 receptor agonist brands may enhance acceptance and demand.

Oral semaglutide must be taken with no more than four ounces of water and separated from other medications to optimize absorption, due to its co-formulated absorption enhancer. Although administered daily, it retains a prolonged half-life of approximately one week, comparable to injectable formulations. The daily schedule reflects bioavailability constraints rather than rapid clearance.

On February 9, 2026, Novo Nordisk announced that it had filed a lawsuit against Hims & Hers, alleging patent infringement over compounded semaglutide products. The document goes on to suggest that these drugs are technically unapproved and therefore may be unsafe for consumers, particularly given that oral Wegovy is the only GLP-1 pill to receive approval from the FDA.

Prior supply constraints affecting both injectable and oral semaglutide formulations have largely been eliminated, with consistent access across doses now reported in routine clinical practice. Despite restored availability, new market entrants—including Hims & Hers—have introduced lower-cost oral semaglutide offerings, prompting swift legal action from Novo Nordisk.

Central to the dispute is the proprietary absorption enhancer (SNAC) required for effective oral semaglutide bioavailability. Oral delivery of GLP-1 receptor agonists presents substantial pharmacokinetic challenges, and the commercial formulation of Wegovy and related oral semaglutide products relies on highly specific absorption technology developed and patented by Novo Nordisk. This enhancer cannot be readily replicated without intellectual property and regulatory implications. Questions arise regarding what excipients or delivery mechanisms compounded versions are employing—and whether these have undergone any formal pharmacologic validation.

Unlike FDA-approved medications, which require extensive phase 1–4 clinical trial evaluation, compounded alternatives may enter the market without rigorous assessment of pharmacodynamics, pharmacokinetics, dose proportionality, or long-term safety. Given the inherent difficulty of achieving adequate gastrointestinal absorption of peptide-based therapies, some compounded oral semaglutide products may offer minimal systemic exposure, effectively functioning as placebos. At worst, the use of untested absorption enhancers or excipients could introduce unanticipated toxicity.

Substantial progress in price reductions has been made compared with earlier list prices exceeding $1,000 per month, with current branded options beginning at considerably lower entry points. With commercial supply stabilized, FDA-approved therapies are advocated to ensure both therapeutic integrity and patient safety.