Novo Nordisk has announced several new initiatives to reinforce patient access to authentic, FDA-approved Wegovy (semaglutide), following the expiration of the FDA’s grace period that allowed mass compounding of semaglutide during a shortage of the drug. The initiatives also aim to curb the spread of illicit compounded semaglutide, much of which is sourced from unregulated foreign suppliers, primarily in China, according to Novo Nordisk.¹

Why is Novo Nordisk Intensifying Efforts to Secure Safe Access to Wegovy?

"Mass compounding of 'semaglutide' is illegal, dangerous, and must stop now, which is why we are doubling down on our commitment to accessibility, availability, and affordability of authentic, FDA-approved Wegovy," said Dave Moore, EVP, US operations, Novo Nordisk, in a press release. "Novo Nordisk always puts patient safety first, and we urge all stakeholders, including the FDA, Boards of Pharmacy, and law enforcement, to take decisive action to uphold the highest quality standards of care."

Discounted Pricing and Distribution Channels for Patients

As part of the initiative, Novo Nordisk launched a limited-time savings offer for self-paying patients new to Wegovy, pricing the first month at $199 and subsequent months at $499 through June 30, 2025. Access will be available via prescriptions from local healthcare providers, telehealth platforms integrated with NovoCare Pharmacy, or directly through NovoCare, with fulfillment handled by CenterWell Pharmacy. Additionally, patients can explore potential insurance coverage and co-pay savings at Wegovy.com.¹

Background on NovoCare Pharmacy and Expanded Savings Access

Novo Nordisk first launched NovoCare Pharmacy in March to improve access for patients without insurance or those those whose insurance does not cover Wegovy. Later that month, the company expanded the availability of the discount program to include local pharmacies for cash-paying patients, aiming to protect them from potentially harmful knockoffs not approved by the FDA.²

FDA Shortage Declaration and Temporary Compounding Extensions

Due to high demand, semaglutide was placed on the FDA’s drug shortage list in 2022, as Novo Nordisk struggled to keep pace with prescriptions. In February 2025, the FDA declared the shortage resolved.

To minimize treatment disruptions, the agency issued temporary extensions for compounders. Under Section 503A of the FD&C Act, state-licensed pharmacies and physicians were permitted to continue compounding semaglutide injection products that are essentially copies of FDA-approved drugs until April 22, 2025.

Under Section 503B, outsourcing facilities were granted an extension until May 22, 2025. However, the agency reserved the right to take enforcement action for other regulatory or statutory violations, including when a product is found to be substandard or poses safety risks.^2,3

Commitment to Supply and Patient Safety

"We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand,” said Moore, in a February press release. “No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients. "Patient safety remains our top priority and, in line with our purpose to improve lives and health, we continue to partner, educate, and advocate for expanded, affordable access to our medicines for those who need and rely on them."⁴

Legal Actions and Public Education Campaigns

Looking ahead, Novo Nordisk plans to continue its legal and public education campaigns. It is launching a new awareness initiative, "Choose the Real Thing," and expanding its "Check Before You Inject" campaign to inform patients about the risks of counterfeit or altered versions of semaglutide. The company also reported that it has filed nearly 120 lawsuits across 34 states against compounders and distributors accused of making misleading claims or selling unapproved semaglutide products.¹

References

1. New Novo Nordisk initiatives support patient access to authentic, FDA-approved Wegovy® as federal ban on mass compounding of "semaglutide" takes effect. PR Newswire. May 22, 2025. Accessed May 23, 2025. https://prnmedia.prnewswire.com/news-releases/new-novo-nordisk-initiatives-support-patient-access-to-authentic-fda-approved-wegovy-as-federal-ban-on-mass-compounding-of-semaglutide-takes-effect-302463064.html

2. Novo Nordisk Expands Discounted Access to Wegovy. PharmExec. March 25, 2025. Accessed May 23, 2025. https://www.pharmexec.com/view/novo-nordisk-expands-discounted-access-wegovy

3. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. FDA. April 28, 2025. Accessed May 23, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize

4. FDA declares Wegovy® and Ozempic® shortage is over and that Novo Nordisk is fully meeting or exceeding nationwide demand for all doses. PR Newswire. February 21, 2025. Accessed May 23, 2025. https://www.prnewswire.com/news-releases/fda-declares-wegovy-and-ozempic-shortage-is-over-and-that-novo-nordisk-is-fully-meeting-or-exceeding-nationwide-demand-for-all-doses-302382370.html