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What’s Going On with the Wegovy & Ozempic Shortage
Update: Wegovy Shortage to Continue Into 2024
According to a news release on CNN on August 10, 2023, Novo Nordisk expected supply restrictions on starter doses of the weight loss medicine Wegovy to persist into 2024, several months beyond its previous prediction. Now that we are in 2024, we can say their prediction was somewhat correct. Even though some doses of Wegovy are now available again after the shortages, supplies are still expected to be limited. According to a recent statement made by the manufacturers “overall demand will continue to exceed supply and some patients may still have difficulty filling Wegovy® prescriptions”.
Wegovy and Ozempic have continued to be all over the news into 2024 as more and more people are looking to tackle weight loss issues. With chronic obesity in the US at 42.4%, this means that more than 4 in 10 adults in the United States are obese. To clarify, obesity is defined as having a body mass index (BMI) of 30 or higher.
In June of 2021, hope for those who have struggled with chronic obesity came when the FDA approved Wegovy (semaglutide) for weight loss in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol). Ozempic is not specifically approved for weight loss, so taking it for this purpose constitutes off-label use. The problem now is that no one can get it. Let’s take a closer look at what is really going on with the Wegovy shortage.
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What Is Causing the Shortage?
While supply chain issues have been a cause of medicine shortages in recent years, the current shortage is most likely tied to the rapid increase in prescriptions. In the first quarter of 2022, Wegovy was prescribed to over 1.2 million people in the United States. This represents an increase of over 500% from the first quarter of 2021. It’s estimated that in 2023, doctors nationwide were writing 100,000 new prescriptions every week.
But now, in 2024 after only 4 months into the year, the company is now seeing 25,000 new U.S. patients begin Wegovy® on a weekly basis, and apparently the number is still growing. This is already roughly four times the amount of patients who were starting Wegovy not long ago in December 2023.
In reality, the shortage is the result of a combination of extremely high demand and global supply issues. The manufacturer still cannot keep up.
How Will the Wegovy and Ozempic Shortage Be Resolved?
Going forward, Novo Nordisk is taking steps to mitigate the continuing shortage, but ending it permanently looks unlikely in the near future. To help, they have focused on increasing its manufacturing capacity and resolving supply chain disruptions. These measures include:
- Adding a new manufacturing facility in the United States.
- Increasing production at existing manufacturing facilities.
- Securing additional supplies of raw materials and components.
In their 2023 annual report, Novo Nordisk said they will have dedicated almost $11 billion to expanding global production capacity. Along with gradually increasing the overall supply of the lower doses of Wegovy throughout the rest of 2024, the company is also looking at ways to switch from single-injections to weekly injections in an effort to combat the shortage.
In addition, Novo Nordisk reports that they are pausing some key Wegovy® promotional efforts to avoid stimulating further demand. In addition, Novo Nordisk will closely manage Wegovy® shipments to wholesalers in the U.S. with a plan to create a more steady level of inventory, despite supply constraints.
Who Can Get Wegovy Right Now?
After the 2023 shortage, a recent release by the U.S. and Federal Drug Administration (FDA) listed that the 1.7 milligram (mg) dose of Wegovy is now available again after having been previously listed as limited availability due to the increased demand as discussed.
According to other reports, “[i]t joins Novo’s 2.4 milligram Wegovy dose as the only two doses not in shortage.”
Alternatively, be aware that the three lower doses including 0.25 milligram, 0.5 milligram and 1 milligram Wegovy injectors are still listed as “limited availability”. Novo Nordisk and the FDA have not yet determined when supplies might be able to normalize this year.
You can find more information on the current and resolved drug shortages and discontinuations reported to the FDA here.
Regarding patients, Novo Nordisk said that it is “working with healthcare providers to help patients who are currently taking Wegovy to continue their treatment.” The company said that it is “providing information and resources to help patients find Wegovy and understand their options.” On the Novo Nordisk website, they issue regular updates explaining their position. This year, they stated the following:
“We will continue to manage shipments, limiting quantities of the lower dose strengths (0.25 mg, 0.5 mg, 1 mg) to U.S. wholesalers for distribution to retail pharmacies, in an effort to support continuity of care for existing patients.”
What Does This Mean?
If you have not already started Wegovy, the available medications will be distributed to existing patients. If you are just starting Wegovy and if medication is available, your prescription will be started at the lowest dosage and increased gradually depending on your response. They recommend that if you are having challenges filling your prescriptions that you may want to look at other options with your healthcare professional so this shortage does not halt your obesity treatment planning.
The Impact on Patients
The Wegovy shortage is a major challenge for patients who are trying to lose weight. Wegovy is one of the most effective weight-loss drugs available, and its shortage has made it more difficult for people to achieve their weight-loss goals.
Patients who are unable to get Wegovy may need to consider other weight loss prescriptions such as Saxenda and Metformin. There are many online weight-loss companies that can create a holistic approach to weight loss that includes helping you get a different medication.
Note that Wegovy is also now available under Medicare Part D since it is a self-administered injectable drug, which consists of “Medicare’s outpatient drug benefit offered by private stand-alone drug plans and Medicare Advantage plans”.
The Wegovy shortage is a reminder of the importance of having access to effective weight-loss medications. Obesity is a serious health problem, and it is important to have treatments that can help people lose weight and improve their health.
What About Generic Semaglutide
There is currently no generic form of Semaglutide. Many health and wellness spas have advertised generic semaglutide injections. This is a formula created by a compounding pharmacy that takes small amounts of the original ingredient, or versions of the ingredient, and combines it with other ingredients. This process is not transparent and it can be very difficult to determine what is in the formulation.
According to the FDA, patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.
In a June 2023 press release, Novo Nordisk began the process of filing lawsuits against health and wellness spas that are promoting generic forms of Semaglutide, and the compounding pharmacies producing them.
When Will Wegovy Go Generic?
According to DrugPatentWatch.com, Wegovy was eligible for patent challenges on December 5, 2021. By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 5, 2031. This may change due to patent challenges or generic licensing. It’s possible that a generic version of Wegovy could be available sooner if a patent challenge is successful.
In Summary
The current Wegovy shortage is driven mainly by the radical increase of prescriptions. Wegovy is actively working to increase production, but it is expected that the shortage will continue until the end of September 2023. There is no generic version of Wegovy and a generic version isn’t expected to be available until December 2031.
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