Fasenra patent expiration?

Fasenra (ben ralizumab) – Patent Landscape & When They’re Set to Expire

What Fasenra is:

• A fully human, anti‑IL‑5 receptor α (IL‑5Rα) monoclonal antibody.
• Approved by the FDA in 2017 for severe eosinophilic asthma that is uncontrolled on oral steroids and at least one other controller.
• Sold under the brand name Fasenra by AstraZeneca (now part of Pfizer as of 2024).

1. Key Types of Patents Held for Benralizumab

Why these matters – The CoM patents are the “gold standard” for biosimilars. Once the CoM patents expire, other companies can legally develop a “biosimilar” that has the same amino‑acid sequence and structure. The use‑in‑disease patents, while less critical for biosimilar approval, can still delay marketing of a biosimilar for the same indication.

2. Expected U.S. Patent Expiration Timeline

Bottom line – In the United States, the first patent that could open a window for a biosimilar in the asthma indication is likely 2026 (use‑in‑disease). The CoM patents will still be active until 2029–2030, meaning that any biosimilar would need to demonstrate identical sequence and structure before those dates.

3. European (EU) Patent Status

Why it matters – In the EU, the first patent that could potentially be challenged or allow entry of a biosimilar is also around 2026–2027. European patent protection is typically shorter than in the U.S. due to the 20‑year term from filing, but the “priority” dates can shift the effective expiry.

4. What This Means for Market Dynamics

5. Practical Take‑aways for Different Stakeholders

6. Quick Reference: Patent Expiration Calendar (U.S.)