Copycat Drugs and the Rise of Imitation Weight-Loss Medications

The United States Food and Drug Administration (FDA) approved the drug ‘Ozempic’ for use in 2017, to treat type-2 diabetes. Developed to lower blood sugar levels in type-2 diabetic patients, it functions by mimicking the hormone GLP -1. However, its renown stems, not from its medical effectiveness, but rather from its impact on body weight, as it helps patients lose weight more quickly and effectively than previously possible. Consequently, another drug, Wegovy, with the same active ingredients as Ozempic, was recently approved by the FDA, to assist with weight loss. Both drugs have been hailed as pharmaceutical triumphs, as they have sparked a cosmetic revolution while continuing to be medically necessary. 

Ozempic’s effectiveness has been analysed by the Center for Disease Control and Prevention (CDC), wherein they identified ‘semaglutide’ as the ingredient responsible for an average weight loss of 15% amongst patients. As 42% of Americans are in the obese category of BMI, this drug is highly marketable as it can regulate weight without much effort. Seemingly overnight, these effects were popularised by major Hollywood celebrities such as Oprah Winfrey and Sharon Osborne flaunting their dramatic weight loss transformations. Its public impact was significant with a 436% rise in US Google searches for ‘Ozempic’ over the last five years as well the hashtag ‘Ozempic’ receiving more than 690 million views on TikTok and Instagram. With Ozempic being touted as a weight loss wonder drug, it is unsurprising that it has surpassed its intended use as a treatment for diabetes and has instead become the backbone of a multibillion-dollar weight loss phenomenon.

Patents
As is standard in the pharmaceutical industry, Ozempic and Wegovy have been patented. This means it is illegal for a third party to make, use, import, or sell drugs with the same formula as the patented drugs without the consent of the owner of the patent, which herein, is Novo Nordisk. As a giant in the pharmaceutical industry, the company has taken all precautions to ensure their continued monopoly over the Ozempic formula. In addition, to protect the novel chemical entity of semaglutide itself, Novo Nordisk has an additional 220 ‘secondary’ patent applications in 28 countries. With the core patents set to expire in 2026 and the secondary in 2033, in theory, Novo Nordisk could have market exclusivity over semaglutide until 2033. However, with billions to be made, outsiders are desperate to enter the market sooner rather than later.

Development in other markets
China and India are lobbying to create an Ozempic alternative. With 40.3% of Indians and 50.7% of Chinese adults being overweight, the market for weight loss drugs is immense. Chinese drugmakers are already in the process of developing at least 15 generic versions of Ozempic. As manufacturing superpowers, these countries pose a significant threat to Novo Nordisk, which according to Prashant Nair, director of Mumbai-based Ambit Capital, “does not have enough manufacturing capacity” to cope with global demand. It is, therefore, foreseeable that as soon as the patents expire, pharmaceutical companies in India and China will flood the market with cheaper versions of Ozempic and Weygovy. 

$1bn Shadow Industry
Conversely, some companies are unwilling to wait that long, leading to the creation of a billion-dollar imitation weight loss medication industry. With a rapidly growing global demand for these weight loss drugs and Novo Nordisk currently monopolising supply, it is unsurprising that a shadow industry has emerged. Counterfeit versions of semaglutide can already be found in at least 28 countries, 11 of which have the same batch name (MP5B060), suggesting they came from the same source. These fake drugs are attracting customers desperate for a low-cost alternative to quick weight loss, with copycat versions retailing around $200 a pen, compared to $1000 in the US. Novo Nordisk’s lawyers are constantly battling against patent infringement worldwide as companies falsely call their product ‘Ozempic’ or illegally try to replicate the formula. 

Medical Consequences
Ozempic usage is not without risk, and users are warned of potential side effects such as diabetic retinopathy, gallbladder disease, kidney problems, and hypoglycemia. However, the medical risks associated with counterfeit versions are considerably worse as these products have not gone through the same years of rigorous FDA testing as Ozempic and Wegovy. The World Health Organisation has warned that “these falsified products could have harmful effects on people’s health” and advised that “healthcare professionals, regulatory authorities and the public be aware of these falsified batches of medicine.” The imitation drugs have already been linked to more than two dozen cases of serious harm globally, including two deaths in the USA, adding to the growing fatality rate caused by fake pharmaceuticals. According to WHO, counterfeit drugs kill around a million people each year, such as the painkiller Oxycontin, which led to nearly 55,000 deaths in the US alone in 2021.

A look to the future
As we get closer to the expiration of these patents, it is clear that there will be a great deal of interest in the mass production of these drugs. The UK Prime Minister, Sir Keir Starmer, has openly said that he believes these  “drugs could be very important for our economy and health,” citing stress on the NHS, as well as improving the economy, through helping overweight people “get back into work.” On September 4 2024, the NHS began prescribing Wegovy for obese patients. As their weight falls, profits at Novo Nordisk will rise and undoubtedly tempt more companies to try and replicate this ‘wonder drug’.

By: Amelia Pettit