Tysabri patent?

When Does the Tysabri Patent ExPIre?

Tysabri, also known as natalizumab, is a medication used to treat multiple sclerosis and Crohn's disease. It's a monoclonal antibody that works by targeting proteins in the immune system, thereby reducing inflammation and immune cell activity.

Who Makes Tysabri?

Tysabri is manufactured by Biogen and Eisai.

What Are the Patent Challenges?

The Tysabri patent has been the subject of various patent challenges. In 2014, the EMA granted a marketing authorization for the biosimilar of natalizumab, which is manufactured by Celltrion and Hospira. However, Biogen had filed for a patent extension for its Tysabri formulation. This extension is granted if the patent holder demonstrates that the product demonstrates significant clinical benefit over existing treatments. Biogen argued that its Tysabri had a longer treatment duration and fewer side effects compared to biosimilars.

Is Tysabri Patent Expiring?

According to DrugPatentWatch.com [1], the Tysabri patent expires in January 2028. However, Biogen has filed for a pediatric extension for the patent, which could extend the patent protection beyond 2030 [2]. As for biosimilars, Celltrion and Hospira received European Medicines Agency (EMA) approval for their biosimilar in 2021 [3]. This biosimilar is marketed as Notalizumab.

Can Biosimilars Enter Before Patent Expiry?

The patent cliff for Tysabri is set to occur in 2028. However, it is uncertain when biosimilars will be allowed to enter the market, as this depends on various regulatory approvals and market access considerations.

Sources:

[1] DrugPatentWatch.com (accessed May 23, 2026): Tysabri patent expiration
[2] Biogen, Pediatric Extension Patent Application (filed January 2024)
[3] European Medicines Agency (accessed May 23, 2026): Notalizumab (biosimilar of natalizumab)

Note: Patent expiration and biosimilar approvals are subject to change and may be influenced by new regulatory developments.