The difference between Ozempic and compounded semaglutide and the myth of “generic” versions
Between social media chatter, news outlet coverage, and information discussed at other weight loss clinics, we know there is a lot of misinformation and confusion surrounding GLP-1 receptor agonist medications. Namely, “What is the difference between Ozempic and compounded semaglutide? Aren’t they the same thing?”
The short answer is NO! But we understand why this gets confusing, and this post will hopefully help clarify things.
First and foremost, here at Premier Weight Loss, we do not sell compounded semaglutide or tirzepatide. The products you receive from us are brand name, authentic Ozempic, Wegovy, and Mounjaro. We only offer quality, FDA-approved medications that have been tested, regulated, and proven effective.
So – what is Ozempic, and is there a generic version available?
Ozempic and Wegovy are medications produced by Novo Nordisk, a United States pharmaceutical company. These medications share the same active ingredient – semaglutide – but are marketed for two reasons (Ozempic is FDA-approved for diabetes while Wegovy is FDA-approved for weight loss).
Novo Nordisk has patents on these medications and their active ingredient – semaglutide – meaning they are the only legal producer of this ingredient. Because of this, no generic version of this medication is currently available. Per this article posted by the Washington Post on June 7, 2023, “a true generic drug is an FDA-approved product that has been proven to be the equivalent of the branded product – that the ingredients are of the same quality and that the same amount of gets into the bloodstream, where it lingers for the same amount of time.” The article continues, “the FDA went on to warn that there are no generic versions of these drugs currently” and that instead patients are getting compounded versions.
What is compounding?
Compounding and compounding pharmacies were created to tailor/alter medications based on patient needs. For example, suppose a patient is allergic to a component of a medication. In that case, a compounding pharmacy can sometimes remove that part of the medication to allow the patient to take it safely.
So, while compounding can be beneficial for some patients, an article from September 10, 2020, posted by the FDA, states, “compounded drugs are not FDA-approved. This means the FDA does not review these drugs to evaluate their safety, effectiveness, or quality before reaching patients.” Because of this, the article explains, there have been many cases of serious injuries to patients linked to poor-quality compounded medications. For example, “in 2012”, the article continues, “contaminated drugs compounded by a Massachusetts pharmacy led to more than 750 cases of infection and more than 60 deaths of patients in 20 states.”
Because the FDA does not regulate compounded products, there is no way to know what you get in the medication. The Today Show highlights this very issue, reporting, “The FDA says it has received reports some compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate, which are different from the active ingredient used in Ozempic and Wegovy. Products containing these salts are not safe and effective.”
Novo Nordisk and Eli Lilly, the pharmaceutical company responsible for producing Mounjaro (tirzepatide), have publicly stated that they do not provide semaglutide or tirzepatide, respectively, to any compounding pharmacies. Lilly said, “Compounded versions of tirzepatide can expose users to “potentially serious health risks.”
The Bottom Line:
In conclusion, no true generic versions of Ozempic, Wegovy, or Mounjaro are available on the market today. Instead, patients receive compounded versions of the active ingredients – semaglutide and tirzepatide. Compounded products are not FDA-regulated, can contain other ingredients (such as salts or vitamins) that have not been studied, and can be potentially dangerous. We believe in authenticity and safety, and if it is determined that you qualify* for this medication, we assure you that you are receiving a bona fide product.
(*qualifications are determined by our providers as it is unsafe or recommended to be on these medications without medical evaluation; see “Do I Qualify for GLP-1 Medications?” for further details.)
TLDR: Key points
- Premier Weight Loss does not sell “compounded” or “generic” semaglutide or tirzepatide. We only sell authentic, brand-name Ozempic, Wegovy, and Mounjaro.
- “Compounded” semaglutide/tirzepatide and “generic” semaglutide/tirzepatide mean the same thing. “Generic” versions of Ozempic, Wegovy, and Mounjaro do not exist. If a company claims to have “generic” versions, you are receiving compounded versions of these medications.
- Compounded semaglutide and tirzepatide are not FDA regulated, meaning their efficacy has not been studied and they can potentially be dangerous as there is no regulation of what the product is or where it is coming from.
Sources:
1. “There’s No Such Thing as Generic Ozempic or Wegovy” https://www.washingtonpost.com/business/2023/06/07/generic-ozempic-and-wegovy-don-t-exist-the-fda-is-right-to-warn-patients/1982b92a-053b-11ee-b74a-5bdd335d4fa2_story.html
2. U.S. Food & Drug Administration: “Compounding Laws and Policies”
https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies
3. “Is the compound version of Ozempic safe for weight loss?” https://www.today.com/health/diet-fitness/compounded-ozempic-wegovy-safety-rcna75913
4. “Maker of diabetes drug Mounjaro takes legal action against compounders, spas, and wellness centers”
https://www.cnn.com/2023/09/19/health/eli-lilly-mounjaro-compound-lawsuit/index.html