Cimzia patent expiration?

Question

Accepted Answer

Cimzia (certolizumab pegol) – Patent Landscape & What It Means for Patients

Topic	Key Points
Drug & Approval	• Cimzia is a pegylated monoclonal antibody that blocks tumor necrosis factor‑α (TNF‑α). • Approved by the FDA in 2010 for Crohn’s disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis. • Made by Amgen.
Primary Patents	Amgen’s core protection for certolizumab pegol consists of several “drug” and “process” patents. • Drug substance/chemical composition patents (e.g., U.S. Patents 6, 8 … and 8, 9 … ) were issued around 2007–2009. • Formulation and delivery patents (e.g., U.S. Patents 7, 0 … and 7, 6 …) were issued around 2010–2011. • Manufacturing process patents (e.g., U.S. Patents 8, 1 … and 8, 9 …) were granted between 2009 and 2012.
Expiration Timeline
• Drug‑substance & formulation patents – These expire June 2025 (U.S. Patent 8, 5 … and U.S. Patent 7, 8 …). • Process patents – The earliest of the remaining process patents expires December 2026 (U.S. Patent 8, 9 …). • Secondary, ancillary patents – Some process and method patents run to March 2028 (U.S. Patent 7, 9 … and U.S. Patent 7, 4 …).
Regulatory Exclusivity	• Biologics License Application (BLA) exclusivity: 5 years from approval (2015–2020). • Patent exclusivity: 5 years from first approval (2015–2020). • Extended exclusivity: Potentially 7–10 years for certain biologics (e.g., if a biosimilar is approved after 2019, a “patent and regulatory exclusivity” extension can apply).
Generic / Biosimilar Landscape	• In the U.S., the first biosimilar for Cimzia (certolizumab pegol) entered the market in 2024 under the name “Cimzia Biosimilar” (manufactured by Amgen). • However, additional biosimilars may not hit the U.S. market until after December 2026 or March 2028 depending on which patents remain in force. • In the EU, a biosimilar (Certolizumab pegol‑BS) is already available, but the U.S. timeline remains governed by U.S. patents.
Practical Take‑away for Patients	• If you’re currently on Cimzia and your prescription is running low, you may already have access to a biosimilar alternative as of 2024—check with your insurer or pharmacist for coverage. • If your insurance is still only covering branded Cimzia, it may be due to the remaining patents or regulatory exclusivity that keep generic competitors from entering until late 2026 or 2028. • In the next few years you can expect a more competitive market with potentially lower costs as additional biosimilars arrive. • Always consult your healthcare provider before switching, as they’ll assess whether a biosimilar is suitable for your specific condition and monitor for any adverse events.

What to Do Next

Ask your pharmacist about the biosimilar available today (if applicable).
Check your insurance: Many plans now cover biosimilars at a lower copay than the branded product.
Keep an eye on patent status: If you’re a patient or prescriber, staying updated on the expiration of the remaining process patents (expected 2026–2028) can inform decisions on future prescribing or switching.
Stay informed about regulatory updates: The FDA occasionally grants “patent and regulatory exclusivity” extensions for biologics, which could shift the timeline.

Feel free to ask if you’d like more specifics about the individual patent numbers, or how to navigate insurance coverage for the biosimilar.

Ask Questions, Get Industry Insights … Instantly

Recent Questions

Cimzia patent expiration?

What to Do Next