Is Semaglutide Patented? (Is the Compounded Version Legal?)

A patent is a form of intellectual property that grants exclusive rights to an inventor or assignee for a limited period in exchange for public disclosure of their invention. This means that only the patent holder has the right to make, use, sell, or import their patented invention without permission from anyone else.

In the case of semaglutide, Novo Nordisk, the pharmaceutical company that developed and manufactured the drug, holds several patents. This gives them exclusive rights to produce and sell semaglutide marketed at Ozempic® and WeGovy®.

However, compounding pharmacies may be able to create their version with the same active ingredient as Ozempic® or WeGovy® for patients with a valid prescription from their licensed healthcare provider. Compounded medications are custom-made prescriptions created by specially trained pharmacists to meet the specific needs of patients who cannot use or do not have access to commercially available drugs. 

Medications may be compounded for various reasons, but the FDA does not verify the drug for its safety, effectiveness or quality. This may sound a bit complicated, but follow along for more details about compounded semaglutide. 

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Key Takeaways

• Novo Nordisk holds several patents on semaglutide, which gives them exclusive rights to produce and sell FDA-approved Ozempic® and WeGovy®.
• This does not restrict licensed compounding pharmacies from creating a compounded version of semaglutide for patients with a valid prescription.
• Trained pharmacists create compounded medications to meet the specific needs of patients who cannot use or do not have access to commercially available drugs.
• It is important to note that the compounding process may not produce an exact replica of the original drug, and is not FDA verified for safety, effectiveness or quality.

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Is Semaglutide a Patented Drug?

There are two semaglutide-based drugs patented by Novo Nordisk - Ozempic® and Wegovy®.

Ozempic® is FDA-approved for type 2 diabetes and improved glycemic control. Wegovy® is the brand name for semaglutide used in treating obesity and is also FDA-approved for weight loss.

Patents held by Novo Nordisk protect these two drugs. This means that no other company can make and sell Ozempic® or Wegovy® without seeking permission from Novo Nordisk.

However, since Novo Nordisk is unable to meet the growing demand for semaglutide- which is currently on the FDA’s drug shortages list-  compounding pharmacies may compound the drug given certain conditions detailed in federal law are met. 

Pharmacies licensed by state and with a compounding certification from the Pharmacy Compounding Accreditation Board (PCAB) are allowed to customize medications for patients to meet their individual needs. For example, these pharmacies are allowed to compound semaglutide for patients who are allergic to ingredients in Ozempic® or Wegovy® (removing a specific ingredient) or need a different dosage strength.The active ingredient remains the same across.

Ensure you are purchasing compounded semaglutide from a FDA-licensed pharmacy. Also, remember that you have the right to require independent testing results of how the compounded version was stored and the purity of ingredients.

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Semaglutide Patent Expiration

Which patent are we referring to? Novo Nordisk has multiple patents for semaglutide and its medications. The basic patent covers the compound itself and its therapeutic use. 

However, besides the main patent, Novo Nordisk has over 20 patent families and over 220 patents and patent applications branching out from those families in 28 countries worldwide. Those patents, we can refer to as secondary semaglutide patents, protect different aspects of the compound, including its formulations, methods of production and delivery, combinations with other drugs, and more. These patents have varying expiration dates, some as early as 2021 and others extending into the late 2030s.

So, while the basic patent for semaglutide will expire in 2026, there are still many secondary patents protecting various aspects of the drug that could potentially delay or limit generic competition.

Until 2033, Novo Nordisk can continue to exclusively manufacture semaglutide formulations.

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Compounded Semaglutide - How to Source?

Right now, no one has complete control over how different pharmacies or clinics compound and dispense semaglutide. Besides, many compounding pharmacies might not have the resources or expertise to compound semaglutide properly, leading to potential risks and uncertainties for patients.

You should consult with your licensed healthcare provider to determine whether compounded semaglutide is an option for your metabolic health journey. We recommend checking whether the pharmacy you are purchasing from is and FDA-licensed compounding pharmacy. 

Also, note that semaglutide should only be taken if prescribed by a healthcare professional, and it's effective only when combined with necessary lifestyle and diet changes.

More detailed information about semaglutide can be found in Try Eden's detailed guide.

And if you opt for a compounded semaglutide option right now, Try Eden allows you to get it from licensed pharmacies only after a thorough screening process to ensure safety and effectiveness.

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Reasons Why Pharmacies Compound Drugs

Compounded semaglutide should not be viewed as unsafe or illegal. In fact, there are many valid reasons why pharmacies compound drugs, including semaglutide. Compounding allows customized dosages and delivery methods to better suit individual patient needs and preferences. It may also help patients who have allergies or sensitivities to certain ingredients in commercially available medications.

When a certain drug is in short supply but many depend on it, compounding can provide a solution for patients who are unable to access their medication through traditional channels. In these cases, pharmacies are allowed to create medications similar to the original drug.

Furthermore, compounded semaglutide may be more affordable for some patients than the commercially available version. This is especially helpful for those without insurance coverage or with high co-pays for prescription medications.

So, it may be a good idea to discuss compounded semaglutide with your healthcare provider and see if it's a viable option for you. They can help determine whether it's safe and appropriate for your health needs.

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Customize Medication For Patient Needs

Compounding may be a valuable solution when patients need an individual dosage differing from the commercially available options for semaglutide. This is particularly useful for patients with chronic conditions that require long-term medication use. Compounded drugs may be tailored to meet specific dosage requirements and help achieve optimal results.

For example, a patient may require a smaller or larger dose of semaglutide than commercially available. A compounding pharmacy can prepare the medication in the exact dosage the patient needs, ensuring they receive the proper amount for their condition.

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Shortages

When commercially available medication is unavailable, compounded medication may be an option. Compounding pharmacies can create medications that are currently unavailable in the market due to shortages or discontinuations by manufacturers. This may allow patients to continue their treatment without interruption and avoid potential health complications.

For example, during a shortage of semaglutide, many may face the challenge of finding a consistent supply of the medication. Very many patients use compounded semaglutide nowadays to continue their treatment without interruption. This is especially beneficial for patients with conditions dependent on a specific medication.

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Cost

Last but not least, cost may differ from patient to patient based on their insurance coverage. In certain cases, compounded medications may be affordable than their branded counterparts. This may be because compounded drugs are not subject to the same patent laws and regulations as commercially available medications, allowing lower prices and thus, allowing access for patients who may struggle with high medication costs.

In addition, compounding pharmacies may work with insurance companies to reduce the financial burden on patients. This may be helpful for patients who require long-term use of semaglutide and may otherwise face significant out-of-pocket expenses.

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FAQ

Is compounded semaglutide available?

Yes, compounded semaglutide is available and may be taken with a licensed healthcare provider’s prescription. FDA-licensed compounding pharmacies must adhere to guidelines and safety protocols when creating compounded medications..

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‌Disclaimer: The FDA does not approve compounded medications for safety, quality or manufacturing. Prescriptions and a medical evaluation are required for certain products. The information provided on this blog is for general informational purposes only. It is not intended as a substitute for professional advice from a qualified healthcare professional and should not be relied upon as personal health advice. The information contained in this blog is not meant to diagnose, treat, cure, or prevent any disease. Readers are advised to consult with a qualified healthcare professional for any medical concerns including side effects. Use of this blog's information is at your own risk. The blog owner is not responsible for any adverse effects, or consequences resulting from the use of any suggestions or information provided in this blog.

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Final Thoughts

Ozempic® and Wegovy® are patented, branded versions of semaglutide. Compounding pharmacies use the same active ingredient to create compounded semaglutide, which is available with a licensed healthcare provider’s prescription. Semaglutide may be effective in managing T-2 diabetes and weight management. 

Patients should always consult their healthcare provider and only obtain medications from reputable sources to ensure their safety and well-being.

Explore Try Eden for more information about compounded semaglutide. 

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