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. Over the next ten years, almost half of the world’s 20 best-selling drugs will lose their market exclusivity. What pharmaceutical companies will prepare for the coming competition? Pay attention to the key drugs whose patents will expire in 2023.
Key drugs whose patent will expire in 2023
Humira
- AbbVie
- Sales in 2021: $20.7 bn
- Main patent expiring: 2023
AbbVie’s Humira (adalimumab), alongside the Covid-19 vaccines, was the world’s best-selling drug in 2021. Humira accounted for about 43 per cent of AbbVie’s total sales in 2021. The patent expiration will affect the US pharmaceutical company. The main patent for Humira expired in 2016, however AbbVie has also secured over 200 different surrounding patents, which protect the product well into the future.
This protection was challenged by Amgen in US. 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 reached a handful of settlements regarding Humira in the US with some companies.
Januvia & Janumet
- Merck
- Sales in 2021: $1.4 bn
- Main patent expiring: 2022 – 2023 ⇒ 2027 ?
In September 2022, Merck won ruling upholding diabetes-treatment patent, which are Januvia and Janumet, at U.S. appeals court. The patents in the case cover the dihydrogen phosphate salt of sitagliptin and the co-formulation of sitagliptin and metformin found in Janumet, Merck said. Viatris is angling to market U.S. generics of the big-selling diabetes medicines. However, unlike the other generic companies, Viatris has opted against a patent settlement and instead took its arguments to trial.
Earlier 2022, Januvia was set to lose U.S. exclusivity in January 2023. However, Merck cautioned that if 2027 salt/polymorph patent is protected, would acquire generic manufacturers from making sitagliptin phosphate salt and polymorphic forms until 2027. This means that Merck could have secured itself several more years of exclusivity for the medicine.
Victoza
- Novo Nordisk
- Sales in 2021: $ 2.2 bn
- Main patent expiring: 2022 – 2023
Novo Nordisk’s GLP-1 inhibitor Victoza (semaglutide) is an ongoing generational change. Newer GLP-1 treatments have already overtaken Victoza in terms of sales. 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 received extended FDA approval for the use of Victoza even in younger type 2 diabetics aged 10 – 17 years. Therefore, it could postpone the launch of Teva’s Victoza copy further into the future.
Stelara
- Johnson & Johnson
- Sales in 2021: $5.94bn
- Main patent expiring: 2023
It will navigate a challenging period around the same time, with the company’s top-selling drug Stelara (ustekinumab) expected to lose patent protection in the US in 2023, followed by Simponi (golimumab) in 2024. Alvotech and Teva are coming for Johnson & Johnson’s Stelara crown. Alvotech has partnered with Teva for potential U.S. marketing. In May 2022, Alvotech touted positive results from a pharmacokinetic similarity study. According to the annual report, J&J doesn’t have long before its U.S. composition of patent matter for Stelara expires in 2023. Stelara generated around 10% of J&J’s global sales in 2021. Meanwhile, J&J sued Amgen over plan to sell drug similar to blockbuster Stelara in November 2022.
J&J sues Amgen over plan to sell drug similar to blockbuster Stelara by Reuters
Conclusion
Best-selling pharma providers make some strategies to maintain their business and protect the exclusivity as possbile as they can. Some new law may affect life science industry as well. Those will have impact on the supply chain and stock market. Let’s see how it will work in 2023.
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