Ultomiris patent expiry?

When will the main eculizumab patent expire?
The U.S. patent covering the antibody structure and key manufacturing process for eculizumab (sold as Ultomiris) is set to expire in 2034, giving Pfizer a 15‑year monopoly beyond the drug’s 2019 launch.
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What other exclusivity protections still apply?
Ultomiris benefits from orphan drug exclusivity granted in 2019, which lasts seven years, and a 10‑year marketing exclusivity that was extended in 2021. These stay in force until 2039.
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Can a biosimilar enter the market before the patents end?
No. Biosimilars must wait until the patents, exclusivity periods, and any regulatory data‑protected patents expire or are invalidated. The next likely entry point is around 2034–2039.
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How will patent expiry change pricing?
When the patents lapse, generic or biosimilar competitors can offer lower‑priced alternatives, likely driving the list price of Ultomiris down by 30–50 %.
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Which patents could still shield Ultomiris after 2034?
Additional patents cover formulation, delivery devices, and specific use in atypical hemolytic uremic syndrome. These are set to expire between 2036 and 2040, so Pfizer may maintain market control until then.
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When might a competitor’s version appear?
If Pfizer’s patents lapse without a challenge, competitors could file for FDA approval as early as 2035. If patents are contested, this could shift earlier.
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Who owns the patents and how long will they hold them?
Pfizer holds the primary patents on eculizumab. They maintain ownership until the stated expiration dates, after which rights revert to the public domain.
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Sources
[1] https://www.drugpatentwatch.com/ultomiris