As 2022 draws to a close, it is not just Christmas and New Year celebrations that are on the agenda. Some of the world’s largest pharmaceutical companies are preparing for expiring patents, which are expected to have a major effect on several of the world’s best-selling drugs. BioStock has listed some of the drugs facing expiring patents in the coming years.

Over the next ten years, almost half of the world’s 20 best-selling drugs will lose their market exclusivity, according to a report from the analysis company Moody’s that FiercePharma reports on. The pharmaceutical giants behind the bestsellers are doing what they can to prepare for the coming competition.

Trying to strengthen the protection for its bestsellers

BioStock recently wrote an article about American Merck, that is working feverishly to strengthen the position of the cancer drug Keytruda on the market. You can read the article here. Merck, however, is still a few years away from key patent expiry for Keytruda in 2028. There are other companies whose patent expiration is significantly closer and BioStock has listed some of these at the bottom of this article.

For the sake of clarity, it may be worth mentioning that it can be difficult to know exactly when a drug loses its patent protection, especially when dealing with blockbusters. Often, the large companies make sure to protect their product with a solid patent portfolio that makes it difficult for competitors to make copies of the drug, or as it is called in the case of biological drugs, biosimilars. It is not uncommon for a copy to enter the market via court hearings.

Humira’s patent expiration is expected to have a major impact on the pharmaceutical market

One such example is Abbvie’s Humira (adalimumab), which, alongside the Covid-19 vaccines, was the world’s best-selling drug in 2021. With sales of 19.8 BUSD, Humira accounted for about 43 per cent of Abbvie’s total sales last year, so it is safe to say that the patent expiration will affect the US pharmaceutical company. The main patent for Humira expired in 2016, but Abbvie has also secured over 200 different surrounding patents, which protect the product well into the future.

However, this protection was challenged by American Amgen and in 2017 the two companies reached a settlement, where Amgen received a patent license and thus the green light to launch its biosimilar Amgevita in the US in 2023. Abbvie has since reached a handful of settlements regarding Humira in the US with companies such as Boehringer Ingelheim, Pfizer, Samsung Bioepis, Mylan and Sandoz.

Heir lined up

Another bestseller facing patent expiration is Novo Nordisk’s GLP-1 inhibitor Victoza (semaglutide). In this case, there is an ongoing generational change, where newer GLP-1 treatments have already overtaken Victoza in terms of sales.

However, this does not mean that Novo Nordisk does not put energy into defending Victoza, which in 2021 sold for more than 15 billion DKK. In 2019, the company reached a settlement with Israeli generics company Teva Pharmaceuticals to keep Victoza copies off the market until late 2023. Novo Nordisk has since received extended FDA approval for the use of Victoza even in younger type 2 diabetics aged 10 – 17 years, something that could postpone the launch of Teva’s Victoza copy further into the future.

AstraZeneca continues to defend Symbicort

Teva has also shared the courtroom with Swedish-British AstraZeneca, regarding the asthma and COPD treatment Symbicort. The product, which sold for 2.7 BUSD in 2021, is a combination of the two active ingredients formoterol and budesonide. The patent for the combination itself expired back in 2012 in the EU and 2014 in the US, but the company is fighting tooth and nail to keep Symbicort alive for as long as possible.

AstraZeneca suffered a legal defeat in the autumn to Viatris and Kindeva, who accuses the company of delaying generics from reaching patients in the United States. The parties will soon go back to court, this time to dispute a formulation patent, which is already expired in the EU and which expires in the US in 2023.

Sees no patent obstacles to launch

Another company that has targeted the Symbicort combination is Swedish Iconovo, that together with Amneal Pharmaceuticals is developing a generic version based on the ICOres inhaler. The company plans to launch the product in 2024 and does not see any patent obstacles before the launch. In the Nordic region, the launch will be carried out by the subsidiary Iconovo Pharma, which Fredrik Radencrantz, Director Business Development, tells us more about in an interview here.

List of upcoming expiring main patents

In this article, we have touched on some of the blockbuster drugs that are in the midst of or headed for expiring patents. We have listed more examples below:

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