When Will Semaglutide Be Generic?

How soon will we have a generic version of Ozempic, Wegovy, or Rybelsus? Here’s how soon you can expect generic semaglutide.

When Will Semaglutide Be Generic? featured image

Introduction

If you’re among thousands who’ve experienced results on Ozempic or Wegovy, then you must feel they’ve been worth every penny. These semaglutide brands not only help lower your blood sugar levels, they also promote weight loss.

As effective and as popular as they may be, they’re not exactly within everyone’s budget. Weight loss drugs, for one, are known to be on the pricey side. Someone taking semaglutide can easily spend around $1,000 for a month’s worth of treatments.

How can Ozempic and Wegovy become more affordable? Is there a generic semaglutide? Why or why not? In this article, we look at the conditions for a drug to have a generic version, and what’s in store for it.

What is semaglutide?

As massively popular Ozempic and Wegovy may be, not everyone is familiar with how exactly their active ingredient semaglutide works. Knowing the science will give you a better appreciation of why people are willing to pay a premium for it.

Semaglutide belongs to a class of drugs, glucagon-like peptide-1 receptor agonists, or GLP-1 Ras, for short. Basically, it mimics how a hormone, GLP-1, prompts the pancreas to release insulin, which regulates high blood sugar levels.

At the same time, the drug also has another effect, slower gastric emptying. It is the process when food exits the gut and enters the small intestine. 

Because digestion is slower than usual, people taking semaglutide tend to feel fuller for longer. In addition, they have fewer food cravings because they don’t think about food as much. Apart from this, the medication also sends signals to the brain that you’re already full.

Taking semaglutide?

You can take semaglutide in two ways—either orally or subcutaneously (injecting under the skin). Brands Ozempic and Wegovy both come in injectable dosing pens, while Rybelsus comes in tablet form. 

Off-label prescription

Ozempic and Rybelsus both have FDA approval to treat type 2 diabetes, while Wegovy has FDA approval to treat obesity. However, they offer the same therapeutic benefits of regulating blood sugar levels and managing weight. This is why many healthcare providers prescribe Ozempic and Rybelsus off-label for weight loss.

Dosage and administration

Proper dosage, administration, and storage of semaglutide are key to maintaining its efficacy. Your healthcare provider will typically start you on a low dose, gradually increasing this until you reach a maintenance dose. This is to allow your body to get used to the drug.

You administer Ozempic and Wegovy once weekly regardless of meals in the upper arm, thigh, or abdomen. For Rybelsus, meanwhile, you take it once daily on an empty stomach. The best time to take semaglutide is according to its manufacturer’s dosage schedule.

It’s important you follow the specific steps every time you administer semaglutide to ensure that it works at its best. Your healthcare provider should be able to demonstrate how to properly administer the medicine. Moreover, he or she can address any questions or clarifications you may have as well.

For best results, take semaglutide along with a healthy diet and exercise.

Missed doses

If you miss a dose of Ozempic, don’t worry. Just take the missed dose immediately within five days after the day of the missed dose. If it’s been more than five days, skip the missed dose and proceed with the next dose as scheduled.

On the other hand, if you miss a dose of Wegovy and the next is over two days away, take the missed dose ASAP. If the next dose is less than two days away, skip the missed dose. Next, take the following scheduled dose of Wegovy. If you miss a dose for over two weeks, use it on the next scheduled day of the dose. You may also want to consult your doctor about restarting the treatment.

For missed Rybelsus doses, just take the next dose the following day. 

It’s important that you adhere to the prescribed schedule of taking semaglutide. This ensures that a consistent level of medication is in your bloodstream.

Safety of semaglutide

With Ozempic and Wegovy’s popularity, we’re sure you’re confident in its safety and efficacy. Still, it’s always good to know the clinical trials that these drugs went through to secure FDA approval.

In the STEP 5 trial, researchers investigated the two-year effects of semaglutide in adults who were overweight or with obesity. Participants lost an average of 15 percent of their body weight with semaglutide. Meanwhile, those in the placebo group lost approximately 2.6 percent of their body weight. 

Participants who took semaglutide also lost 14.4 centimeters or 5.7 inches off their waist circumference. Additionally, they saw improvements in their systolic blood pressure by 5.7 mmHg. Participants in the semaglutide group also experienced better diastolic blood pressure, blood sugar levels, total cholesterol, and triglycerides.

A December 2022 study found that semaglutide users lost more body fat than body mass and had a weaker appetite. In addition, they had better control of eating, and had fewer food cravings, especially for greasy foods. 

Side effects

Yes. Just like any other drug, semaglutide has potential side effects. Thankfully, though, these are generally mild and can be managed with the help of your doctor. Also, the more serious adverse reactions are rare.

Gastrointestinal reactions account for 10% or more of semaglutide’s side effects. These include: 

  • nausea (up to 44% of cases), 
  • diarrhea (up to 30%), 
  • vomiting (up to 24%), 
  • constipation (up to 24%), 
  • abdominal pain (up to 20%), 

Other common side effects of semaglutide which occur in 1 to 10% of cases include indigestion, belching, gassiness, gastroenteritis, or gastritis. Gastroentertis is short-term infection and inflammation of the digestive system, while gastritis is inflammation of the stomach lining.   

Why is there no generic Ozempic?

Because Danish pharmaceutical company, Novo Nordisk, developed semaglutide, they have a patent on the drug until December 5, 2031. Until then, only Novo Nordisk can produce semaglutide.

Still, there’s a chance that this date can still be changed. In Brazil, for instance, Novo Nordisk appealed for a patent extension. Although this was denied, we can expect the drugmaker to make similar appeals in other countries.

The patent also temporarily allows them to charge how much they want for the medicine. This enables them to recover the costs of running clinical trials, among other semaglutide-related expenditures.

Why semaglutide is expensive

Apart from the skyrocketing market demand, Novo Nordik’s patent is also largely the reason why semaglutide is rather expensive. 

Semaglutide is also priced significantly higher in the US than in other wealthy nations like Japan, Canada, Switzerland, and Germany. According to research by the Peterson-KFF Health System Tracker, Ozempic in the US costs five times than Ozempic in Japan.

This may have something to do with the US’ rates of obesity among its peer nations. A third of adults in the US have obesity, versus 17.1 percent in other countries.

Novo Nordisk stated that the pricing reflects “efficacy, innovation, extensive clinical trials, and clinical value we believe our products deliver.” Also, other countries have different regulatory requirements for pricing.

Cheaper versions of semaglutide

Currently, Medicare—US federal health insurance for people aged 65 and above—covers Ozempic for type 2 diabetes, but not for weight loss. In some cases, Medicaid—the state and federal health program for low-income people—covers most GLP-1 agonists such as semaglutide.

When Novo Nordisk’s patent lapses in 2031, other drug-making companies can start manufacturing their generic versions of semaglutide. By then, it’s expected to be priced more competitively.

Available alternatives

There are other drugs that consumers can try while a generic version of Ozempic or Wegovy is not yet available. These include the active ingredients liraglutide (Saxenda, Victoza), dulaglutide (Trulicity), tirzepatide (Mounjaro), albiglutide (Tanzeum), and exenatide (Byetta). These are all injectable medications that are either administered daily once weekly, or twice weekly.

You might have also already heard about compounded semaglutide. These are versions that still contain semaglutide, but with the addition of other ingredients, such as vitamins. 

While the FDA has approved some drugstores to custom-mix variations of semaglutide, some reports cite adverse effects from these. Novo Nordisk and Eli Lilly have also reported impurities in the compounded medications.

Other reports have noted that salt forms of semaglutide, such as semaglutide sodium and semaglutide acetate, were uused by compounders.

Although compounded semaglutide offers a cheaper alternative, it must be from an outsourcing facility or a state-licensed pharmacy. If you are buying semaglutide online, make sure you are purchasing from a valid and reputable online pharmacy.

The FDA has caught illegally marketed semaglutide online and has issued warning letters to stop these potentially counterfeit products. They contain little to no semaglutide, as well as other harmful ingredients. Additionally, it is also investigating reported counterfeit Ozempic in the US.

Conclusion

Currently, there is no generic version of semaglutide. Novo Nordisk’s patent for the drug lapses in 2031.

Until then, only the Danish drugmaker can manufacture semaglutide and dictate its price on the market. It allows the company to recover expenses from clinical trials and other semaglutide-related spending.

Alternatives are available to treat type 2 diabetes and obesity, such as liraglutide (Saxenda, Victoza), dulaglutide (Trulicity), exenatide (Byetta), albiglutide (Tanzeum), and tirzepatide (Mounjaro). 

Although there are FDA-approved custom-mix versions of semaglutide, there have been reports of compounders using salt forms of semaglutide. These can be potentially dangerous to patients’ health.

If you are planning to switch from semaglutide to other type 2 diabetes or obesity medications, consult your healthcare provider.

Glossary of terms:

  • GLP-1: Glucagon-like peptide-1 is a gut-based hormone involved in the secretion of insulin to lower blood sugar levels typically elevated after meals.
  • GLP-1 Ra: Glucagon-like peptide-1 receptor agonist. It mimics the actions of GLP-1.
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