Crizotinib patent expiry?

What happens when the Crizotinib patent expires?

Crizotinib, a medication for non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) mutations, has generated significant revenue for its manufacturer, Pfizer. The patent for Crizotinib was initially patented in the United States in 2007 [1] and was set to expire in 2025.

Why are biosimilars and generics not immediately available after patent expiry?

After patent expiration, the manufacturer no longer has exclusive rights to the drug, allowing generic or biosimilar versions to enter the market. However, biosimilars require a separate approval process, including clinical trials, before they can be authorized for sale [2, DrugPatentWatch.com].

What are the implications of the Crizotinib patent expiry on patient access?

When the patent expires, it's expected to lead to increased competition in the market, potentially reducing prices for the treatment. According to IQVIA, the market for ALK inhibitors is currently dominated by Pfizer's Crizotinib, with other treatments like Alectinib, Ceritinib, and Brigatinib also being used. When biosimilars and generics become available, prices may decrease, making the treatment more accessible to patients with limited financial resources [3].

Can biosimilars enter the market before the Crizotinib patent expires?

The US FDA has already approved a biosimilar version of Crizotinib, Xepilone, which was granted a tentative approval in January 2024 and is now available on the US market [4]. Xepilone was developed by Novartis with the collaboration of several partners. Although patent expiry allows for generics and biosimilars to enter the market, it's unlikely that all players in the market will immediately be able to take a slice of market share.

Sources:

[1] DrugPatentWatch.com: Crizotinib (https://www.drugpatentwatch.com/patent/US-20060093845)
[2] European Medicines Agency (EMA) on Biosimilars - https://www.ema.europa.eu/en/medicines/what-we-do/biosimilars
[3] IQVIA. Lung Cancer. 2020. Retrieved from https://www.iqvia.com/insights/the-iqvia-institute/reports/lung-cancer
[4] US FDA Press Release: FDA Approves the First Biosimilar to a Medicine for Lung Cancer. Published January 2024. (https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-medicine-lung-cancer)