In just a couple of years, brand-name injectable drugs equivalent to Ozempic, Wegovy, Mounjaro and Zepbound have gained popularity. Billion dollar annual sellers For weight reduction in addition to controlling blood sugar levels and reducing the danger of heart disease.
But these injections cost so much: they’ve a price. About US$800-$1,000 per monthAnd if used alone for weight reduction, they aren’t. Covered by most insurance policies.. Both drugs mimic the naturally occurring hormone GLP-1 to assist control blood sugar and reduce cravings. They can only be taken with a prescription.
The Food and Drug Administration announced an official phase-out of the lively ingredient in these drugs in 2022, but on October 2, 2024, the agency announced that The shortage of tirzepatide drugs has been addressed.lively component in Mounjaro and Zepbound.
Despite the increasing demand and limited supply of those drugs, no generic version is obtainable. This is because patents for semaglutide – the lively ingredient in Ozempic and Vigovi, which remains to be in brief supply – and terceptide Not ending until 2033. And 2036respectively
As a result, Non-brand substitutes which might be bought with or and not using a prescription are flooding the market. Yet these products include real risks for consumers.
I am a pharmacist. which studies weaknesses in federal oversight. Prescription and Over-the-counter medications And Dietary supplements My research group within the US has recently investigated the loopholes. Which are allowing alternative weight loss products. to enter the market.
High demand is driving GLP-1 wannabes.
The dietary complement market has tried to capture the demand for GLP-1 with pills, teas, extracts, and all types of other products. Claims to produce similar effects. Like the brand name at a much cheaper price.
Herbal products offer only one A few pounds of weight lossWhile many dietary supplements contain weight reduction products. Stimulants such as sibutramine and laxatives such as phenolphthaleinwhich increases the danger. Heart attacks, strokes And Cancer.
The role of compounding pharmacies
Unlike dietary supplements which are masquerading as GLP-1 weight reduction products, compounding pharmacies can create customized versions of products that contain the identical lively ingredients as the actual thing for patients who for some reason Cannot use brand or generic products.
This pharmacy Alternative versions of brand-name drugs may additionally be produced when there’s a shortage of official drugs.
As the demand for GLP-1 drugs has outstripped supply, compounding pharmacies are producing the drugs legally. Different types of semaglutide and tirzepatide products.
These products may are available in versions that differ from brand-name firms, equivalent to vials of powder to be dissolved in liquid, or as tablets or nasal sprays.
Just like brand-name drugs, it’s essential to have a legitimate prescription to get them. Prices From $250-$400 per month – Still a steep price for a lot of users.
Compounding pharmacies must comply. FDA Sterility and Standard Manufacturing Practicesbut these rules aren’t as strict for compounding pharmacies as they’re for industrial manufacturers of generic drugs.
In addition, pharmacies prepare compounding products. No need to test in humans. for safety or effectiveness as brand name products do.
Adequate dosing will also be difficult with compounded types of medication.
The firms that operate the system.
For those that cannot afford a compounding pharmacy product, or cannot obtain a legitimate prescription for semaglutide or tirzeptide, opportunistic firms are stepping in to fill the gap. These include “peptide companies,” manufacturers that make non-FDA-approved knock-off versions of medicine.
From November 2023 to March 2024, my team conducted a study to judge which of those peptide firms were selling semaglutide or tirzepatide products. We scoured the web searching for these peptide firms and gathered details about what they were selling and their sales methods.
We found that peptide sellers a The way to sell these drugs. On their web sites, firms state that their drugs are for “research purposes only” or “not for human use,” but do nothing to confirm that buyers are researchers or that the product is a research product. Going into the power.
Reading the comments sections of company web sites and targeted ads on social media, it's clear that each buyers and sellers understand the charade. Unlike compounding pharmacies, these peptide sellers don’t provide the equipment you’ll want to dissolve and inject the drug, provide no instructions, and usually don’t answer questions.
Peptide sellers, since they aren’t purportedly selling to consumers, don’t need a legitimate prescription and can sell consumers whatever drug they need to buy. Even if an individual has an eating disorder eg anorexia nervosafirms will gladly sell them a semaglutide or tarzeptide product and not using a prescription. Average prices for these peptide products are $181-$203 per thirty days.
Skirting regulations
Peptide sellers do not need to follow the foundations or regulations that drug manufacturers or compounding pharmacies do. Many firms state that their products are 99 percent pure, but one Independent investigation of three companies Products from August 2023 to March 2024 found that the purity of the product was much lower than promised.
A product Contains endotoxin – a toxic substance produced by bacteria – suggesting that it was contaminated with microbes. In addition, the promised doses of the products were 29% to 39% lower. Poor hygiene could make patients experience Fever, chills, nauseaSkin irritation, infection and low blood pressure.
In the study, some firms never shipped the drug, telling buyers they needed to pay an extra fee to maintain the product clear.
If the user is Damaged by poor quality productsit could be difficult to sue the vendor, because the products specifically state that they’re “not for human consumption.” Ultimately, consumers are being lured into spending money on products which will never arrive, may cause infection, may not have the right dosage, and lack knowledge about the way to use or store the product safely. There are not any instructions.
Will the costs of name name products be lower?
To compete with these alternative sellers, the pharmaceutical company Eli Lilly launched an offering. An alternate version of its brand name Zepbound Product for weight reduction in September 2024.
Instead of its traditional injection pen products that cost greater than $1,000 for a month's supply, the product is available in vials that patients draw and inject themselves. Patients who take 5 mg of Zipbound each week may receive a vial of the product if the patient buys it through the corporate's online pharmacy and may reveal that they do not need insurance coverage for the drug. The price can be $549 per thirty days.
After one Grilling on Capitol Hill In September 2024, pharmaceutical company Novo Nordisk got here under intense pressure to supply low-cost products for its brand name Wegovy to patients and not using a prescription.
Over the subsequent few years, additional brand name GLP-1 agonist drugs are expected to enter the market. By October 2024, a A handful of these products are in late-phase clinical trials.with such lively ingredients Retatrutide, survodutide And Ecnoglutideand greater than 18 other drug candidates are in early stages of development.
When latest pharmaceutical firms enter this market, they are going to need to offer patients lower prices than Eli Lilly and Novo Nordisk with a purpose to gain market share. This is the almost certainly mid-term solution to reducing the costs of GLP-1 drugs and ending drug shortages out there.