The pharmaceutical industry is bracing itself for a significant shift in the coming years as patents for several blockbuster drugs are set to expire. This development presents both challenges and opportunities for the industry, particularly for biosimilars. In this article, we will delve into the top drugs with patents expiring soon and explore the potential impact on the industry.
Top 10 Drugs with Patents Expiring Soon
Keytruda by Merck & Co.:
Keytruda, a cancer treatment, is expected to lose its patent protection in 2028. This could lead to significant revenue decline, from $33.7 billion in 2028 to $27.4 billion in 2029.Eliquis by Bristol Myers Squibb & Pfizer:
Eliquis, an anticoagulant, is expected to lose its patent protection between 2027 and 2029. This could lead to increased competition from generics and biosimilars.Xarelto by Bayer/J&J:
Xarelto, an anticoagulant, is expected to lose its patent protection in 2026. This could lead to significant revenue decline for Bayer, which currently generates €4,516 million from Xarelto sales.
Biosimilars: The Future of Affordable Healthcare
Biosimilars have been gaining traction in recent years, offering a cost-effective alternative to expensive biological drugs. The European Medicines Agency (EMA) approved its first biosimilar in 2006, and the FDA began regulating biosimilars in 2009. Biosimilars are designed to have no clinically meaningful differences in purity, safety, and efficacy compared to their reference products.
Impact on the Industry
The impending patent expirations present both challenges and opportunities for the pharmaceutical industry. Large pharmaceutical companies will need to adapt to the loss of exclusivity by diversifying their portfolios and exploring new revenue streams. This could lead to increased licensing deals and acquisitions of later-stage biotech companies.
“The expiration of patents and other intellectual property rights for originator biologicals over the next decade opens up opportunities for biosimilars to enter the market, which could lead to reduced costs and increased access to healthcare for patients.”
Conclusion
The expiration of patents for several blockbuster drugs presents a significant shift in the pharmaceutical industry. While it poses challenges for companies, it also opens up opportunities for biosimilars to enter the market. As the industry adapts to these changes, it is crucial to educate physicians and patients about the safety and efficacy of biosimilars to promote their widespread adoption.
Sources:
- Proclinical. (2024, February 16). Top 10 drugs with patents due to expire in the next five years. Retrieved from https://www.proclinical.com/blogs/2024-2/top-10-drugs-with-patents-due-to-expire-in-the-next-5-years
- Gabionline. (n.d.). Biologicals patent expiries. Retrieved from https://www.gabionline.net/biosimilars/general/Biologicals-patent-expiries
- FiercePharma. (2021, July 12). The top 15 blockbuster patent expirations coming this decade. Retrieved from https://www.fiercepharma.com/special-report/top-15-blockbuster-patent-expirations-coming-decade
- RSM US. (2023, November 30). Life sciences eyes give-and-take with IRA and upcoming ‘patent cliff’. Retrieved from https://rsmus.com/insights/industries/life-sciences/life-sciences-eyes-give-and-take-with-ira-and-upcoming-patent-cliff.html
- Center for Biosimilars. (2020, February 11). As Patents Expire, Oncology Biosimilars Poised to Expand, Authors Say. Retrieved from https://www.centerforbiosimilars.com/view/as-patents-expire-oncology-biosimilars-poised-to-expand-authors-say