When will Ozempic go generic?

In this article:

• Generic Ozempic: A misleading term
• Semaglutide vs. Ozempic
• Compounded semaglutide and its ingredients
• Is compounded semaglutide safe?
• Other FDA concerns with compounded semaglutide
• Be cautious with compounded semaglutide online
• Choosing compounded semaglutide with medical guidance
• Other GLP-1 receptor agonists marketed for Type 2 diabetes or weight loss

In this article

• Generic Ozempic: A misleading term
• Semaglutide vs. Ozempic
• Compounded semaglutide and its ingredients
• Is compounded semaglutide safe?
• Other FDA concerns with compounded semaglutide
• Be cautious with compounded semaglutide online
• Choosing compounded semaglutide with medical guidance
• Other GLP-1 receptor agonists marketed for Type 2 diabetes or weight loss

Many people are interested in a generic version of Ozempic (semaglutide), especially since the brand-name drug may be expensive. Ozempic is approved to manage Type 2 diabetes and reduce the risk of heart attacks and strokes in certain people. It’s also commonly prescribed off-label for weight loss. 

However, as a brand-name drug, it can cost over $1,300 per month without insurance, which can be a financial burden for many individuals. Some people have tried cheaper alternatives like compounded semaglutide, but these options may not always be safe or trustworthy. 

Still, there is some good news: A true generic version of Ozempic could be available once the current patent protections expire. This would likely lead to lower prices for consumers. Read on to learn about the current state of semaglutide and how things might change in the next few years for those looking for a generic option.

Generic Ozempic: A misleading term

When people talk about “generic Ozempic,” it can be confusing. Generic drugs usually come into the market after the original drug’s patent expires, allowing competition. However, Novo Nordisk still has patent exclusivity for Ozempic, at least until 2033. This means no drugmakers are producing a true generic version of Ozempic that’s approved by the Food and Drug Administration (FDA).

Some products might claim to be a generic version, but they aren’t FDA approved. These are often sold as compounded drugs containing the same active ingredients as brand-name drugs. Compounding involves customizing medications for specific needs, potentially in different strengths and dosage forms. But the result isn’t the same as having a generic option. 

Without FDA approval, there is no guarantee that these medications will offer the same safety and effectiveness as the brand-name drug. Therefore, it’s important to use caution and consult a healthcare provider when considering these alternatives.

Semaglutide vs. Ozempic

Semaglutide is the active ingredient in Ozempic, which can cause some confusion. The confusion arises because semaglutide is often mentioned as if it were the same as Ozempic, leading people to mistakenly think they are the same or that a generic version of Ozempic is available. Although semaglutide is the generic name for Ozempic, there is currently no approved generic version of Ozempic available.

Semaglutide is part of a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. These drugs help manage blood sugar levels in people with Type 2 diabetes and support weight loss. While Ozempic may be a well-known GLP-1 agonist that contains semaglutide, it’s not the only brand-name drug that contains semaglutide. 

The following brand-name medications contain semaglutide that is given in different dosages or dosage forms:

• Wegovy is a brand-name medication containing semaglutide. Unlike Ozempic, which is approved for diabetes, Wegovy is approved specifically for weight loss in adults and adolescents ages 12 and older. It also recently gained approval for reducing the risk of cardiovascular death, heart attacks, and strokes in adults with obesity or who are overweight with known heart disease. Like Ozempic, Wegovy is taken as a once-weekly injection, but it’s meant to deliver a higher dosage of semaglutide than Ozempic.
• Rybelsus is a different brand-name option that offers semaglutide in pill form. It’s taken orally and is also used to help control blood sugar in people with Type 2 diabetes. Rybelsus may be convenient for those who prefer pills over injections.

Like Ozempic, these other brand-name drugs are not yet available in generic versions. As a result, these medications can be expensive. In addition, while they help many people manage conditions like diabetes and obesity, how well they work can differ from person to person.

Compounded semaglutide and its ingredients

The demand for semaglutide has become so high that brand-name versions like Ozempic and Wegovy are often in short supply. As more people turn to these medications for their effectiveness, pharmacies may have trouble keeping enough on their shelves. This shortage can make it hard for people to get the treatment they need when they need it. 

Compounding pharmacies specialize in making customized medications for patients. This means pharmacists might combine or adjust ingredients for specific health needs. For instance, they might change the dosage or eliminate certain ingredients for those with allergies. Those who have trouble finding Ozempic might turn to a compounding pharmacy offering a custom version of semaglutide.

Compounded semaglutide might contain the following:

• Semaglutide, the active ingredient
• Inactive ingredients, such as:
  • Buffers: To maintain the pH level and stability of the solution
  • Preservatives: To prevent microbial growth
  • Solvents: To help dissolve the semaglutide and facilitate its administration, often including water for injection or saline
• Potential additives, such as:
  • Stabilizers: To ensure the medication remains effective over time
  • Colorants or flavorings: For palatability, particularly in oral formulations

Compounding pharmacists work under strict regulations to ensure that the medications they create are safe and effective. Their practices are legal as long as they follow these guidelines. As a result, patients may have more choices when standard medications aren’t appropriate or, in the case of Ozempic, not readily available.

Is compounded semaglutide safe?

Compounded semaglutide is becoming more popular as people search for alternatives to expensive medications like Ozempic. Some compounding pharmacies offer their versions, claiming they contain the same active ingredient. However, it’s important to consider if these compounded drugs are truly safe. 

Healthcare providers often stress the importance of clinical trials to establish a drug’s safety and effectiveness. Compounded semaglutide does not undergo these trials, which means there might be unknown risks. People using compounded versions should know they are taking it off-label without the extensive testing typical for approved medications.

Potential risks with compounded semaglutide

The FDA has warned against using compounded forms of semaglutide, raising concerns about their safety. Some people have experienced negative health effects, with some needing to go to the hospital due to mistakes in measuring their doses. These errors can happen when patients try to self-administer the medication or when healthcare providers miscalculate the amounts needed.

Additionally, many patients who use compounded semaglutide are not familiar with self-injections. This lack of experience, combined with confusion over different measurement units like milliliters and milligrams, may lead to mistakes in dosing. Therefore, it’s key to know how to properly measure and inject the medication.

To reduce these risks, the FDA recommends that patients consult their healthcare providers or pharmacists about how to accurately measure and give themselves the right dose. Having the right syringe size and clear dosage instructions can play a big part. It’s also important to be aware of the different strengths available for compounded semaglutide.

Other FDA concerns with compounded semaglutide

A major problem with compounded semaglutide is that some compounding pharmacies use different salt forms of semaglutide, like semaglutide sodium and semaglutide acetate. These are not the same as the approved version, which uses the base form of semaglutide. The FDA has pointed out that there is no good reason for using these salt forms in compounded drugs, as they do not meet the legal requirements for what can be compounded. 

Patients should be careful when considering any products labeled as semaglutide. Some may contain these unapproved salt forms, which have not been proven safe or effective. It’s important to get semaglutide only with a prescription from a licensed healthcare provider and to buy it from state-licensed pharmacies or facilities registered with the FDA. 

Side effects of compounded semaglutide

The possible side effects of compounded semaglutide are generally the same as those of brand-name versions like Ozempic. The most common side effects of semaglutide include gastrointestinal ones like nausea, vomiting, stomach pain, constipation, and diarrhea.

In addition to common side effects like nausea and stomach pain, compounded semaglutide may lead to more serious issues. These include an increased risk of thyroid cancer and inflammation of the pancreas, known as pancreatitis. If you experience severe abdominal pain that doesn’t go away, with or without vomiting, it’s important to stop using the medication and call your healthcare provider right away.

Other potential serious side effects include changes in vision and kidney problems. Low blood sugar levels may also occur, especially if you’re taking other medications that lower blood sugar. Symptoms of low blood sugar include dizziness, confusion, and weakness. Compounded semaglutide may also cause allergic reactions. If you notice signs of a severe allergic reaction, such as swelling, difficulty breathing, or a severe rash, seek medical help immediately.

Other side effects are possible depending on the other ingredients included in the preparation. The potential lack of precise measurements of ingredients in compounded versions may add to the risks of adverse effects. 

Be cautious with compounded semaglutide online

Buying Ozempic or compounded semaglutide online might seem like a cheaper option, but there are important risks to consider. Some websites advertise lower prices, but the quality may vary. 

Some compounding pharmacies might source materials from places like China, which can raise questions about quality. American pharmaceutical companies typically follow stricter manufacturing guidelines, which may offer a greater level of assurance. Make sure that any compounded medication comes from a reputable source.

Choosing compounded semaglutide with medical guidance

Compounded semaglutide may be a helpful option for managing weight or blood sugar levels, but it’s important to be careful when considering it.

Here are some simple steps to ensure that compounded semaglutide is safe for you:

1. Talk to a healthcare provider. Before starting, consult with a qualified healthcare professional, like your primary care doctor or an endocrinologist. They can provide advice based on your health situation.
2. Check the pharmacy. Make sure the pharmacy you choose is licensed and follows proper guidelines for compounding medications. This helps ensure the product is made safely and with the right ingredients.
3. Look for FDA warnings. Check whether there are any updated warnings from the FDA about compounded semaglutide. This information may help you avoid potential risks.
4. Discuss side effects. Have a conversation with your healthcare provider about possible side effects and any interactions with other medications you might be taking. 

Choosing compounded semaglutide should always be done with the help of a medical professional who is familiar with your health history and medical needs. This way, you can carefully consider the benefits and any safety concerns.

Other GLP-1 receptor agonists marketed for Type 2 diabetes or weight loss

Various GLP-1 receptor agonists are available for managing Type 2 diabetes or supporting weight loss. These medications work in similar ways to promote insulin production and reduce appetite. 

Here’s a look at other GLP-1 receptor agonists besides Ozempic:

• Victoza: Victoza is a medication that contains liraglutide and is used to improve blood sugar control in adults with Type 2 diabetes. It is typically administered as a daily injection and can help reduce the risk of diabetes-related complications. 
• Saxenda: Saxenda also contains liraglutide, but it is specifically approved for weight management in certain adults. This medication is meant for people with obesity and can be used alongside a reduced-calorie diet and increased physical activity.
• Mounjaro: Mounjaro is a dual-action drug that contains tirzepatide, which is approved for the treatment of Type 2 diabetes. It targets both GLP-1 and GIP receptors, which may lead to improved blood sugar levels and potential weight loss. 
• Zepbound: Zepbound, another medication containing tirzepatide, is specifically approved for weight loss in adults. It works by improving feelings of fullness and reducing hunger, making it easier for people to achieve their weight loss goals.

These medications may differ in how they’re taken and what they’re used for. For people with Type 2 diabetes or obesity, there are various options to choose from. However, diabetes medications and weight loss drugs can cause different side effects, have different costs, and may work differently for each person.

Bottom line

A true generic form of Ozempic is not yet available, as the drug remains under patent protection until at least 2033. Although some compounded forms of semaglutide are marketed as cheaper alternatives, they may not be FDA approved and could pose risks, such as improper dosing or unapproved ingredients.

Use caution when considering compounded semaglutide, and consult a healthcare provider for the safest treatment option. In the future, once the patent expires, a legitimate generic version could offer a safer and more affordable alternative for managing diabetes or weight loss.