Facing the Latest Patent Cliff

The bio/pharma industry is not unfamiliar with “patent cliffs”; however, the current one being faced is notably steep and, in combination with other factors, is set to negatively impact revenues significantly in the near future. A similarly steep patent cliff was experienced by the bio/pharma industry during the 2000s, but at that time industry had the benefit of pricing tailwinds in the United States, helping industry to overcome the related revenue slump (1).

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players and potentially leading the industry to lose up to $400 billion (2). For example, Merck’s humanized antibody therapy, pembrolizumab (Keytruda), is scheduled to lose its patent in 2028; Regeneron/Bayer’s anti-vascular endothelial growth factor therapy, aflibercept (Eylea), is expected to lose its patent either in 2025 or 2026; and Eli Lilly’s glucagon-like peptide-1 receptor agonist, dulaglutide (Trulicity), is set to lose patent protection in 2027 (3).

Furthermore, while this hefty patent cliff is ongoing, industry is also facing a raft of other issues that are straining profit margins. Issues such as newer and more complex therapeutic modalities are trending, which are more expensive for companies to develop and are targeted at smaller patient populations; various geopolitical tensions are causing supply chain concerns; new legislation is shortening the exclusivity period for drugs; and investment being heavily placed on trending disease areas and specific technologies (1).

However, while the patent cliff will need companies to strategically pivot to negate revenue losses, potential opportunities may open up for other companies seeking to develop a generic or biosimilar form of the blockbuster drugs. According to research, many of the biologic therapies that are set to lose their patent exclusivity in the coming years have no biosimilars in development (4). Such a gap in the market could be a lucrative opportunity indeed.

References

1. Möller, C.; Kristic, S.; Walker, G.-C.; Aguilar, J.; Chandran, P. Biopharma’s Patent Cliff Puts Costs Front and Center. BCG, Article, Feb. 18, 2025.
2. DeAngelis, A.; Feuerstein, A. With a Major Patent Cliff Coming, Will JPM Play Host to Some Serious Deal-Making? STAT, Jan. 8, 2025.
3. Burke, H. Top 10 Drugs with Patents Due to Expire in the Next Five Years. Proclinical, Feb. 16, 2024.
4. Jeremias, S. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars. AJMC, Feb. 5, 2025.

About the author

Mike Hennessy Jr is President and CEO of MJH Life Sciences®.

Article details

Pharmaceutical Technology®
Vol. 49, No. 3
April 2025
Page: 8

Citation

When referring to this article, please cite it as Hennessy, M. Facing the Latest Patent Cliff. Pharmaceutical Technology 2025 49 (3).