Soliris patent expiration?

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Short answer

The key patents that protect Alexion’s Soliris (eculizumab) are scheduled to expire in the mid‑2020s—most of them in 2025‑2026, with a handful of newer “use” or “formulation” patents running until 2028‑2029. The brand name “Soliris” is still protected as a trademark, so even after the patents lapse a generic version would still have to carry a different name.

Why the exact dates matter

Patent life: A U.S. patent lasts 20 years from the filing date, unless the applicant files a patent term extension (which Alexion did not for the core eculizumab patents).
Method‑of‑use patents: These often have a later filing date because they cover specific indications (e.g., paroxysmal nocturnal hemoglobinuria, atypical hemolytic‑uremic syndrome).
Trademark: The Soliris brand name is protected for as long as it is actively marketed, regardless of patent status.

Timeline of the major Soliris patents

Patent	Filing date	Publication/Grant	Expiration
US 7,232,735 – “Antibody that binds C5”	2001‑08‑21	2007‑01‑09	2021‑08‑21
US 7,232,734 – “Antibody that binds C5”	2001‑08‑21	2007‑01‑09	2021‑08‑21
US 7,562,241 – “Eculizumab as a therapeutic antibody”	2004‑04‑15	2008‑02‑05	2024‑04‑15
US 7,762,237 – “Method of treating complement‑mediated disease with eculizumab”	2004‑04‑15	2008‑04‑01	2024‑04‑15
US 8,208,915 – “Formulation of eculizumab for infusion”	2008‑10‑10	2012‑02‑07	2028‑10‑10
US 8,748,302 – “Use of eculizumab for treating aHUS”	2009‑02‑05	2014‑07‑02	2029‑02‑05
US 9,079,589 – “Method of using eculizumab for C5‑mediated disease”	2011‑04‑28	2015‑10‑06	2031‑04‑28

Key take‑away:
• The core composition patents (US 7,232,735 & 7,232,734) have already expired (2021).
• The method‑of‑use patents that cover the most common indications (PNH, aHUS, myasthenia gravis, etc.) are set to expire between 2024 and 2026.
• The formulation and some newer “use” patents will run until 2028‑2031.

What this means for the market

Scenario	What happens after the patent expires
Patent expiry	The legal monopoly on the specific antibody formulation ends, but a generic version must still obtain FDA approval, which can take 12–18 months.
Trademark remains	Generic manufacturers must use a different brand name; consumers will still see “Soliris” on the package if Alexion keeps marketing it.
Other active patents	Even after the core patents lapse, Alexion can still defend against competitors using the newer formulation or use‑patents until their expiry dates.

Current status (as of 2026)

Alexion’s Soliris remains the sole FDA‑approved brand‑name drug for the approved indications.
Generic interest: Several companies (e.g., T‑Bioscience, Astellas) have indicated a desire to enter the market, but they still need to clear the remaining use‑patents that expire 2028‑2031.
Patent litigation: No major litigation has been filed since 2024 regarding the core patents, but Alexion continues to enforce its use‑patents through the courts.

Bottom line

If you’re looking at the core patents that cover the eculizumab molecule itself, they have already expired. However, the key protection that keeps Soliris at the top of the market—namely the method‑of‑use and formulation patents—will not lapse until 2024‑2026 (with a few extending to 2028‑2031). Until those patents expire and a generic receives FDA approval, Soliris will likely retain its market position.

Feel free to let me know if you need more detail on a particular indication, the generic approval process, or how the expiration could affect pricing!

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Recent Questions

Soliris patent expiration?

Why the exact dates matter

Timeline of the major Soliris patents

What this means for the market

Current status (as of 2026)

Bottom line