Just as several large pharmaceutical companies faced patent cliffs several years ago, the next six years, another wave of original research drugs face patent limits. A recent EvaluatePharma report stated that between 2018 and 2024, sales of medicines that are about to lose patent protection amounted to US$250 billion. The four companies Ebway, Shinco, Johnson & Johnson and Novo Nordisk suffered the most damage.
Plenty of expired patents
The biggest drug facing patent exclusivity is precisely the world’s best-selling drug, Humira. Abbey’s 2017 financial report shows that Humira’s sales amounted to US$18.4 billion (see: Global Pharmaceutical Sales Data for 2017.xlsx). Although an important U.S. patent of Humira expires in 2016, Eiberville has other patents protected until 2022. From the beginning of 2023, Humira will face competition from at least one biosimilar drug (Amjevita from Amgen). Later this year, Ebervey will face competition from biosimilar drugs in Europe.
The new base of lenalidomide ranked second in sales in 2017, sales reached 8.2 billion US dollars. It is reported that important patents for the drug in Europe will expire in 2022, and US drug patents have been extended to 2026 by the new base. However, Xinji reached an agreement with Natco Pharma to allow the latter to start sales of lenalidomide generic drugs in limited quantities starting from March 2022.
Johnson & Johnson’s Remicade is the world’s best selling anti inflammatory drug. Its sales volume reached 7 billion 728 million US dollars in 2017, ranking fourth. But Johnson has lost the exclusive right to Remicade. In 2024, the company’s patent for another heavy autoimmune disease drug Stelara expired. Last year, Stelara’s sales reached $4 billion 11 million.
Over the past few years, novo Nordisk’s NovoLog/NovoRapid and NovoLog Mix/NovoMix weight loss products have lost exclusive patent rights. Another major patent of Levemir’s company in the United States and Europe will expire in 2019. According to statistics, Novo Nordisk had or will lose the patent exclusive rights of drugs in 2017 total sales of more than 9 billion US dollars.
Risk and Reality
How scary is the patent cliff? Maybe something different from your current feelings. After all, the arrival of a blizzard will not be felt until 2023. On the one hand, selling at risk does not mean that sales will be completely lost; on the other hand, these companies have already striven to increase sales of other products and continue to introduce new drugs.
Analysts pointed out that before 2020, 2021 or even 2024, the impact of the overall sales risk caused by the patent expiration is not necessarily obvious. During the period from 2018 to 2024, about $139 billion of the original research sales will be lost because of the maturity of the patent. Although this is a large number, it is still far below the $250 billion in sales at risk during this period.
For example, Humira is still expected to become the world’s number one drug in 2024, with sales exceeding US$15.2 billion. AbbVe CEO Rick Gonzalez recently stated externally that the approved drugs Imbruvica and Mavyret and the research drugs elagolix and upadacitinib have tremendous growth potential.
Although lenalidomide will slip from second place to third place, it will still maintain strong growth and will generate nearly 8.2 billion U.S. dollars in revenue each year seven years from now. New Base CEO Mark Alles touted several of the company’s promising drug candidates earlier this month, including the multiple sclerosis drug ozanimod, CAR-T therapy JCAR017 and bb2121, and the myelofibrosis drug fedratinib.
Although Johnson & Johnson has lost its patent exclusive rights, analysts predict that the company can hold most of Remicade’s revenue. And Johnson’s strategy has always been controversial, prompting Pfizer to file a lawsuit for alleged violations of the Antitrust Act.
Many analysts do not care much about Novo Nordisk’s patent cliffs. Although the patent expires, Novo Nordisk will remain relatively high. In addition, Novo Nordisk has launched new drugs, in particular, the listing of Somarutai may continue to consolidate its dominance in this segment.