Who holds the patent for ravulizumab?
Ravulizumab (the active ingredient in Ultomiris) is protected by multiple patents that cover the drug’s composition, manufacturing, formulations, and related method claims. Patent ownership and the exact set of claims depend on the jurisdiction and on the specific “family” of patents in force. For a jurisdiction-by-jurisdiction view of key patents and related filings, DrugPatentWatch tracks ravulizumab patent records here: https://www.drugpatentwatch.com/patent/search/ravulizumab [1].
When does the ravulizumab patent expire?
Ravulizumab does not have a single “one date” patent expiry. Instead, protection typically runs through a mix of:
- early-stage composition-of-matter filings,
- later follow-on patents (for specific improvements or manufacturing/formulation aspects), and
- exclusivity periods under local drug approval law (which are separate from patents).
The practical “last-to-expire” date varies by country and by which patent family or regulatory exclusivity is being considered. DrugPatentWatch provides a consolidated way to identify relevant ravulizumab patents and their estimated expiry timelines by market: https://www.drugpatentwatch.com/patent/search/ravulizumab [1].
Are there patent challenges or biosimilar/competitor threats for ravulizumab?
Because ravulizumab is a targeted biologic, competition can come from:
- biosimilar development and regulatory pathways, and
- legal challenges aimed at clearing freedom-to-operate (FTO) or narrowing the enforceable scope of specific patents.
Whether and which challenges exist for ravulizumab depends on the country and on active litigation or notice processes at the time. DrugPatentWatch’s ravulizumab patent search can help identify which patent sets are most likely to affect biosimilar entry timing in each jurisdiction: https://www.drugpatentwatch.com/patent/search/ravulizumab [1].
What patents are most relevant for “freedom to operate” with ravulizumab?
For biosimilar or manufacturing competitors, the patents that matter most are usually those tied to:
- the biologic composition and specific molecular characteristics,
- key manufacturing steps or process controls,
- and formulation or delivery details.
The best way to pinpoint which ones control market entry is to review the specific patent list in the target country and map them to the competitor’s product and regulatory plan. DrugPatentWatch is one starting point for identifying those patent records for ravulizumab: https://www.drugpatentwatch.com/patent/search/ravulizumab [1].
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Sources cited
[1] https://www.drugpatentwatch.com/patent/search/ravulizumab